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    Clinical Trial Results:
    A PLACEBO-CONTROLLED, ESCALATING DOSE, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES

    Summary
    EudraCT number
    2010-020730-26
    Trial protocol
    FR  
    Global end of trial date
    13 Nov 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    30 May 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    A0081074
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00437281
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 East 42nd Street,, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center , Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center , Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the escalating single- and multiple-dose safety and tolerability of pregabalin, in comparison to placebo, in pediatric subjects 1 month through 16 years of age with partial onset seizures. To evaluate the single-dose and steady-state pharmacokinetics of pregabalin in pediatric subjects 1 month through 16 years of age with partial onset seizures.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Apr 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 58
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Mexico: 4
    Worldwide total number of subjects
    65
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    16
    Children (2-11 years)
    34
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects who completed this study and who tolerated study medication were eligible to enroll in study A0081075 (NCT00448916), a 12-month open-label extension study of pregabalin.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Arm description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Arm description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administerd on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Arm description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Arm description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Placebo (Age Cohort: 1 to 23 Months)
    Arm description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 2 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Arm description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Arm description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Arm description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Arm description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Placebo (Age Cohort: 2 to 6 Years)
    Arm description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Arm description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Arm description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Arm description
    Subjects of 7 to 11 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Arm description
    Subjects of 7 to 11 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD-144723
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Placebo (Age Cohort: 7 to 11 Years)
    Arm description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8.Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Arm description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Arm description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Arm description
    Subjects of 12 to 16 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Arm description
    Subjects of 12 to 16 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    PD 0144723
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Arm title
    Placebo (Age Cohort: 12 to 16 Years)
    Arm description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Number of subjects in period 1
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Started
    3
    3
    3
    3
    4
    4
    3
    3
    3
    5
    3
    3
    2
    3
    5
    3
    3
    4
    2
    3
    Completed
    3
    3
    3
    2
    4
    3
    3
    3
    3
    4
    3
    3
    2
    2
    4
    3
    3
    4
    1
    2
    Not completed
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    1
    1
         Adverse event, non-fatal
    -
    -
    -
    1
    -
    1
    -
    -
    -
    1
    -
    -
    -
    1
    1
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administerd on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 2 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years) Total
    Number of subjects
    3 3 3 3 4 4 3 3 3 5 3 3 2 3 5 3 3 4 2 3 65
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    1.2 ± 0.7 1.4 ± 0.5 0.7 ± 0.5 0.6 ± 0.1 1.6 ± 0.3 4 ± 0.8 2.9 ± 0.1 4 ± 1.7 3.9 ± 1.8 3.7 ± 1 9.3 ± 1.2 9.7 ± 2.3 10 ± 0 9 ± 1 9.2 ± 1.5 15.7 ± 0.6 13.7 ± 2.1 14 ± 1.8 15.5 ± 0.7 13 ± 1.7 -
    Gender categorical
    Units: Subjects
        Female
    1 2 1 2 2 4 2 1 1 3 2 1 0 0 4 2 1 0 0 3 32
        Male
    2 1 2 1 2 0 1 2 2 2 1 2 2 3 1 1 2 4 2 0 33

    End points

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    End points reporting groups
    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administerd on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 2 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral capsule in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Subject analysis set title
    Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Primary: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment

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    End point title
    Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment [1]
    End point description
    Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with subject's usual function; Moderate = some interference with subject's usual function; Severe = significant interference with subject's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Subjects may experience more than 1 AE. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline to Day 7
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3
    3
    3
    3
    4
    4
    3
    3
    3
    5
    3
    3
    2
    3
    5
    3
    3
    4
    2
    3
    Units: adverse events
        Mild
    0
    2
    2
    4
    1
    1
    4
    5
    5
    13
    0
    3
    3
    5
    2
    0
    2
    11
    2
    0
        Moderate
    1
    1
    0
    1
    1
    2
    0
    0
    0
    3
    2
    0
    0
    2
    0
    1
    1
    4
    3
    0
        Severe
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment

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    End point title
    Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment [2]
    End point description
    Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with subject's usual function; Moderate = some interference with subject's usual function; Severe = significant interference with subject's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Subjects may experience more than 1 AE. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Day 8 up to 28 days after open-label dose of study medication
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3
    3
    3
    3
    4
    4
    3
    3
    3
    5
    3
    3
    2
    3
    5
    3
    3
    4
    2
    3
    Units: adverse events
        Mild
    0
    0
    0
    1
    2
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Moderate
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
        Severe
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Change in Physical and Neurological Findings

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    End point title
    Number of Subjects With Clinically Significant Change in Physical and Neurological Findings
    End point description
    Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 7 days post-last dose of study medication
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3
    3
    3
    3
    4
    4
    3
    3
    3
    5
    3
    3
    2
    3
    5
    3
    3
    4
    2
    3
    Units: subjects
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: 28-Day Seizure Frequency Rate

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    End point title
    28-Day Seizure Frequency Rate
    End point description
    Seizure frequency was reported by subject's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period) multiplied by (*) 28. Results are not reported since the data was reported in individual subject listings but not summarized for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to 7 days post-last dose of study medication
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    Units: seizure
        number (not applicable)
    Notes
    [3] - Results not reported since the data was reported in individual subject listings but not summarized.
    [4] - Results not reported since the data was reported in individual subject listings but not summarized.
    [5] - Results not reported since the data was reported in individual subject listings but not summarized.
    [6] - Results not reported since the data was reported in individual subject listings but not summarized.
    [7] - Results not reported since the data was reported in individual subject listings but not summarized.
    [8] - Results not reported since the data was reported in individual subject listings but not summarized.
    [9] - Results not reported since the data was reported in individual subject listings but not summarized.
    [10] - Results not reported since the data was reported in individual subject listings but not summarized.
    [11] - Results not reported since the data was reported in individual subject listings but not summarized.
    [12] - Results not reported since the data was reported in individual subject listings but not summarized.
    [13] - Results not reported since the data was reported in individual subject listings but not summarized.
    [14] - Results not reported since the data was reported in individual subject listings but not summarized.
    [15] - Results not reported since the data was reported in individual subject listings but not summarized.
    [16] - Results not reported since the data was reported in individual subject listings but not summarized.
    [17] - Results not reported since the data was reported in individual subject listings but not summarized.
    [18] - Results not reported since the data was reported in individual subject listings but not summarized.
    [19] - Results not reported since the data was reported in individual subject listings but not summarized.
    [20] - Results not reported since the data was reported in individual subject listings but not summarized.
    [21] - Results not reported since the data was reported in individual subject listings but not summarized.
    [22] - Results not reported since the data was reported in individual subject listings but not summarized.
    No statistical analyses for this end point

    Secondary: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis

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    End point title
    Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis [23]
    End point description
    Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for subjects who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose subjects). Results are normalized to individual subject's Day 8 dose. Pharmacokinetic (PK) parameter analysis population included all randomized and treated subjects who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Geometric mean and geometric coefficient of variation (CV) obtained by sampling distribution of 2 subjects were not considered meaningful, hence not analyzed and represnted here as 99999. For number of subjects analyzed= 1, 99999 was reported in place of geometric CV as it was not evaluated.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Multiple-Dose analysis was done only for those subjects who received multiple doses of pregabalin and thus excluded subjects assigned to placebo group.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3 [24]
    3 [25]
    3 [26]
    2 [27]
    3 [28]
    2 [29]
    2 [30]
    3 [31]
    3 [32]
    3 [33]
    1 [34]
    2 [35]
    3 [36]
    3 [37]
    4 [38]
    1 [39]
    Units: (microgram*hour/milliliter)/(mg/kg)
        geometric mean (geometric coefficient of variation)
    7.614 ± 19
    7.563 ± 26
    7.595 ± 6
    99999 ± 99999
    7.962 ± 29
    99999 ± 99999
    99999 ± 99999
    8.203 ± 31
    11.64 ± 29
    9.571 ± 9
    7.59 ± 99999
    99999 ± 99999
    10.2 ± 13
    13.07 ± 34
    9.642 ± 44
    14.4 ± 99999
    Notes
    [24] - Number of subjects analyzed 'N' signifies those subjects who were evaluable for the measure.
    [25] - 'N' signifies those subjects who were evaluable for the measure.
    [26] - 'N' signifies those subjects who were evaluable for the measure.
    [27] - 'N' signifies those subjects who were evaluable for the measure.
    [28] - 'N' signifies those subjects who were evaluable for the measure.
    [29] - 'N' signifies those subjects who were evaluable for the measure.
    [30] - 'N' signifies those subjects who were evaluable for the measure.
    [31] - 'N' signifies those subjects who were evaluable for the measure.
    [32] - 'N' signifies those subjects who were evaluable for the measure.
    [33] - 'N' signifies those subjects who were evaluable for the measure.
    [34] - 'N' signifies those subjects who were evaluable for the measure.
    [35] - 'N' signifies those subjects who were evaluable for the measure.
    [36] - 'N' signifies those subjects who were evaluable for the measure.
    [37] - 'N' signifies those subjects who were evaluable for the measure.
    [38] - 'N' signifies those subjects who were evaluable for the measure.
    [39] - 'N' signifies those subjects who were evaluable for the measure.
    No statistical analyses for this end point

    Secondary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis

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    End point title
    Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis
    End point description
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for subjects who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose subjects). Results are normalized to individual subject's Day 8 dose. PK parameter analysis population. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the subject had PK parameter available in these groups. 99999 is updated here in place geometric CV because number of subjects analysed was 1 and geometric CV cannot be evaluated.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    End point values
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    1 [40]
    1 [41]
    1 [42]
    1 [43]
    1 [44]
    1 [45]
    1 [46]
    1 [47]
    1 [48]
    1 [49]
    1 [50]
    1 [51]
    1 [52]
    1 [53]
    0 [54]
    0 [55]
    Units: (microgram*hour/milliliter)/(mg/kg)
        geometric mean (geometric coefficient of variation)
    6.7 ± 99999
    8.1 ± 99999
    7.05 ± 99999
    7.02 ± 99999
    8.3 ± 99999
    6.38 ± 99999
    8.76 ± 99999
    9.16 ± 99999
    10 ± 99999
    10.1 ± 99999
    8 ± 99999
    15.9 ± 99999
    13.8 ± 99999
    10.6 ± 99999
    ±
    ±
    Notes
    [40] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [41] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [42] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [43] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [44] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [45] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [46] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [47] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [48] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [49] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [50] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [51] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [52] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [53] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [54] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [55] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis

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    End point title
    Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis [56]
    End point description
    Cmax for subjects who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose subjects). Results are normalized to individual subject's Day 8 dose. PK parameter analysis population included all randomized and treated subjects who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Geometric mean and geometric coefficient of variation obtained by sampling distribution of 2 subjects were not considered meaningful, hence not analyzed and represented here as 99999. For number of subjects analyzed= 1, 99999 was reported in place of geometric CV as it was not evaluated.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Multiple-Dose analysis was done only for those subjects who received multiple doses of pregabalin and thus excluded subjects assigned to placebo group.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3 [57]
    3 [58]
    3 [59]
    2 [60]
    3 [61]
    2 [62]
    2 [63]
    3 [64]
    3 [65]
    3 [66]
    1 [67]
    2 [68]
    3 [69]
    3 [70]
    4 [71]
    1 [72]
    Units: microgram (mcg)/milliliter (mL)/(mg/kg)
        geometric mean (geometric coefficient of variation)
    1.468 ± 23
    1.577 ± 11
    1.496 ± 14
    99999 ± 99999
    1.601 ± 13
    99999 ± 99999
    99999 ± 99999
    1.856 ± 15
    2.35 ± 29
    1.66 ± 13
    0.945 ± 99999
    99999 ± 99999
    1.762 ± 22
    2.538 ± 44
    1.355 ± 59
    1.94 ± 99999
    Notes
    [57] - Number of subjects analyzed 'N' signifies those subjects who were evaluable for the measure.
    [58] - 'N' signifies those subjects who were evaluable for the measure.
    [59] - 'N' signifies those subjects who were evaluable for the measure.
    [60] - 'N' signifies those subjects who were evaluable for the measure.
    [61] - 'N' signifies those subjects who were evaluable for the measure.
    [62] - 'N' signifies those subjects who were evaluable for the measure.
    [63] - 'N' signifies those subjects who were evaluable for the measure.
    [64] - 'N' signifies those subjects who were evaluable for the measure.
    [65] - 'N' signifies those subjects who were evaluable for the measure.
    [66] - 'N' signifies those subjects who were evaluable for the measure.
    [67] - 'N' signifies those subjects who were evaluable for the measure.
    [68] - 'N' signifies those subjects who were evaluable for the measure.
    [69] - 'N' signifies those subjects who were evaluable for the measure.
    [70] - 'N' signifies those subjects who were evaluable for the measure.
    [71] - 'N' signifies those subjects who were evaluable for the measure.
    [72] - 'N' signifies those subjects who were evaluable for the measure.
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis

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    End point title
    Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis
    End point description
    Cmax for subjects who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose subjects). Results are normalized to individual subject's Day 8 dose. PK parameter analysis population. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the subject had PK parameter available in these groups. 99999 is updated here in place geometric CV because number of subjects analysed was 1 and geometric CV cannot be evaluated.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    End point values
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    1 [73]
    1 [74]
    1 [75]
    1 [76]
    1 [77]
    1 [78]
    1 [79]
    1 [80]
    1 [81]
    1 [82]
    1 [83]
    1 [84]
    1 [85]
    1 [86]
    0 [87]
    0 [88]
    Units: (mcg/mL)/(mg/kg)
        geometric mean (geometric coefficient of variation)
    1.51 ± 99999
    1.81 ± 99999
    1.18 ± 99999
    1.52 ± 99999
    1.93 ± 99999
    1.5 ± 99999
    1.7 ± 99999
    1.54 ± 99999
    1.31 ± 99999
    2.29 ± 99999
    1.24 ± 99999
    1.28 ± 99999
    1.81 ± 99999
    1.79 ± 99999
    ±
    ±
    Notes
    [73] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [74] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [75] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [76] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [77] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [78] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [79] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [80] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [81] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [82] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [83] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [84] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [85] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [86] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [87] - For pregabalin 10 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    [88] - For pregabalin 15 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis

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    End point title
    Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis [89]
    End point description
    Tmax for subjects who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose subjects). PK parameter analysis population included all randomized and treated subjects who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment).
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    Notes
    [89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Multiple-Dose analysis was done only for those subjects who received multiple doses of pregabalin and thus excluded subjects assigned to placebo group.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3 [90]
    3 [91]
    3 [92]
    2 [93]
    3 [94]
    2 [95]
    2 [96]
    3 [97]
    3 [98]
    3 [99]
    1 [100]
    2 [101]
    3 [102]
    3 [103]
    4 [104]
    1 [105]
    Units: hours
        median (full range (min-max))
    0.617 (0.5 to 1)
    1.05 (1 to 2.08)
    1.12 (1.02 to 2)
    2.49 (0.967 to 4.02)
    0.5 (0.5 to 2)
    1.67 (1.17 to 2.17)
    2.62 (1.17 to 4.07)
    1 (0.967 to 1.17)
    0.583 (0.583 to 1)
    1 (1 to 1)
    4 (4 to 4)
    0.79 (0.5 to 1.08)
    0.5 (0.5 to 4)
    0.583 (0.483 to 1)
    2.09 (1.5 to 8.08)
    2.15 (2.15 to 2.15)
    Notes
    [90] - Number of subjects analyzed 'N' signifies those subjects who were evaluable for the measure.
    [91] - 'N' signifies those subjects who were evaluable for the measure.
    [92] - 'N' signifies those subjects who were evaluable for the measure.
    [93] - 'N' signifies those subjects who were evaluable for the measure.
    [94] - 'N' signifies those subjects who were evaluable for the measure.
    [95] - 'N' signifies those subjects who were evaluable for the measure.
    [96] - 'N' signifies those subjects who were evaluable for the measure.
    [97] - 'N' signifies those subjects who were evaluable for the measure.
    [98] - 'N' signifies those subjects who were evaluable for the measure.
    [99] - 'N' signifies those subjects who were evaluable for the measure.
    [100] - 'N' signifies those subjects who were evaluable for the measure.
    [101] - 'N' signifies those subjects who were evaluable for the measure.
    [102] - 'N' signifies those subjects who were evaluable for the measure.
    [103] - 'N' signifies those subjects who were evaluable for the measure.
    [104] - 'N' signifies those subjects who were evaluable for the measure.
    [105] - 'N' signifies those subjects who were evaluable for the measure.
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis

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    End point title
    Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis
    End point description
    Tmax for subjects who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose subjects). PK parameter analysis population. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the subject had PK parameter available in these groups.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    End point values
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    1
    1
    1
    1
    1
    1
    1
    1
    1
    1
    1
    1
    1
    1
    0 [106]
    0 [107]
    Units: hours
        median (full range (min-max))
    1 (1 to 1)
    0.967 (0.967 to 0.967)
    1.13 (1.13 to 1.13)
    1 (1 to 1)
    0.45 (0.45 to 0.45)
    1 (1 to 1)
    1 (1 to 1)
    1.98 (1.98 to 1.98)
    1 (1 to 1)
    0.583 (0.583 to 0.583)
    2 (2 to 2)
    4 (4 to 4)
    4.05 (4.05 to 4.05)
    1 (1 to 1)
    ( to )
    ( to )
    Notes
    [106] - For pregabalin 10 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    [107] - For pregabalin 15 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    No statistical analyses for this end point

    Secondary: Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis

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    End point title
    Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis [108]
    End point description
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for subjects who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose subjects). PK parameter analysis population included all randomized and treated subjects who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Arithmetic mean and standard deviation obtained by sampling distribution of 2 subjects were not considered meaningful, hence not analyzed and represnted here as 99999. For reporting arms where number of subjects= 1, standard deviation is represented as 99999.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    Notes
    [108] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Multiple-Dose analysis was done only for those subjects who received multiple doses of pregabalin and thus excluded subjects assigned to placebo group.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3 [109]
    3 [110]
    3 [111]
    2 [112]
    1 [113]
    2 [114]
    3 [115]
    3 [116]
    3 [117]
    3 [118]
    2 [119]
    2 [120]
    3 [121]
    3 [122]
    4 [123]
    1 [124]
    Units: hours
        arithmetic mean (standard deviation)
    4.433 ± 0.17559
    3.397 ± 0.58603
    3.263 ± 0.49903
    99999 ± 99999
    3.9 ± 99999
    99999 ± 99999
    3.523 ± 0.25146
    3.52 ± 0.91804
    4.287 ± 0.27737
    4.113 ± 0.25891
    99999 ± 99999
    99999 ± 99999
    4.96 ± 1.3857
    3.953 ± 0.80532
    5.643 ± 0.88921
    6.61 ± 99999
    Notes
    [109] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [110] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [111] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [112] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [113] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [114] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [115] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [116] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [117] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [118] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [119] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [120] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [121] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [122] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [123] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [124] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Plasma Decay Half-Life (t1/2): Single-Dose Analysis

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    End point title
    Plasma Decay Half-Life (t1/2): Single-Dose Analysis
    End point description
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for subjects who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose subjects). PK parameter analysis population. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the subject had PK parameter available in these groups. Number of subjects analzed were only 1, standard deviation was not evaluated and represented here as 99999.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    End point values
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    1 [125]
    1 [126]
    1 [127]
    1 [128]
    1 [129]
    1 [130]
    1 [131]
    1 [132]
    1 [133]
    1 [134]
    1 [135]
    1 [136]
    1 [137]
    1 [138]
    0 [139]
    0 [140]
    Units: hours
        arithmetic mean (standard deviation)
    2.64 ± 99999
    3.78 ± 99999
    3.76 ± 99999
    3.22 ± 99999
    3.88 ± 99999
    2.7 ± 99999
    3.83 ± 99999
    3.08 ± 99999
    4.77 ± 99999
    4.02 ± 99999
    3.13 ± 99999
    6.54 ± 99999
    5.8 ± 99999
    3.85 ± 99999
    ±
    ±
    Notes
    [125] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [126] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [127] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [128] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [129] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [130] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [131] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [132] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [133] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [134] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [135] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [136] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [137] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [138] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [139] - For pregabalin 10 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    [140] - For pregabalin 15 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    No statistical analyses for this end point

    Secondary: Apparent Oral Clearance (CL/F): Multiple-Dose Analysis

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    End point title
    Apparent Oral Clearance (CL/F): Multiple-Dose Analysis [141]
    End point description
    Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for subjects who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose subjects). PK parameter analysis population included all randomized and treated subjects who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Geometric mean and geometric coefficient of variation obtained by sampling distribution of 2 subjects were not considered meaningful, hence not analyzed and represented here as 99999. For reporting arms where number of subjects= 1, standard deviation is represented as 99999.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    Notes
    [141] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Multiple-Dose analysis was done only for those subjects who received multiple doses of pregabalin and thus excluded subjects assigned to placebo group.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    3 [142]
    3 [143]
    3 [144]
    2 [145]
    3 [146]
    2 [147]
    2 [148]
    3 [149]
    3 [150]
    3 [151]
    1 [152]
    2 [153]
    3 [154]
    3 [155]
    4 [156]
    1 [157]
    Units: milliliter/minute (mL/min)
        geometric mean (geometric coefficient of variation)
    19 ± 10
    17.7 ± 47
    18.54 ± 49
    99999 ± 99999
    34.18 ± 61
    99999 ± 99999
    99999 ± 99999
    30.49 ± 9
    58.23 ± 42
    49.49 ± 19
    63.7 ± 99999
    99999 ± 99999
    90.56 ± 26
    78.38 ± 12
    85.87 ± 17
    73.1 ± 99999
    Notes
    [142] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [143] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [144] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [145] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [146] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [147] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [148] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [149] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [150] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [151] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [152] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [153] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [154] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [155] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [156] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [157] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Apparent Oral Clearance (CL/F): Single-Dose Analysis

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    End point title
    Apparent Oral Clearance (CL/F): Single-Dose Analysis
    End point description
    Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for subjects who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose subjects). PK parameter analysis population. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the subject had PK parameter available in these groups. 99999 is updated here in place geometric CV because number of subjects analysed was 1 and geometric CV cannot be evaluated.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
    End point values
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    1 [158]
    1 [159]
    1 [160]
    1 [161]
    1 [162]
    1 [163]
    1 [164]
    1 [165]
    1 [166]
    1 [167]
    1 [168]
    1 [169]
    1 [170]
    1 [171]
    0 [172]
    0 [173]
    Units: mL/min
        geometric mean (geometric coefficient of variation)
    31.5 ± 99999
    24.7 ± 99999
    20.1 ± 99999
    28 ± 99999
    32.3 ± 99999
    60.1 ± 99999
    38.8 ± 99999
    45.5 ± 99999
    58.2 ± 99999
    45.8 ± 99999
    64.8 ± 99999
    54.3 ± 99999
    99.6 ± 99999
    90 ± 99999
    ±
    ±
    Notes
    [158] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [159] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [160] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [161] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [162] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [163] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [164] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [165] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [166] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [167] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [168] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [169] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [170] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [171] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [172] - For pregabalin 10 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    [173] - For pregabalin 15 mg/kg/day for 12 to 16 age cohort no subject had PK parameter available.
    No statistical analyses for this end point

    Secondary: Renal Clearance (CLr): Multiple-Dose Analysis

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    End point title
    Renal Clearance (CLr): Multiple-Dose Analysis [174]
    End point description
    Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for subjects who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose subjects). PK parameter analysis population. Results are not reported for some of the groups since none of the subject had PK parameter available in these groups. Geometric mean and geometric CV obtained by sampling distribution of 2 subjects were not considered meaningful, hence not analyzed and represented here as 99999. For number of subjects analyzed= 1, 99999 was reported in place of geometric CV as it was not evaluated.
    End point type
    Secondary
    End point timeframe
    0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
    Notes
    [174] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Multiple-Dose analysis was done only for those subjects who received multiple doses of pregabalin and thus excluded subjects assigned to placebo group.
    End point values
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    0 [175]
    1 [176]
    0 [177]
    0 [178]
    1 [179]
    0 [180]
    1 [181]
    1 [182]
    0 [183]
    3 [184]
    1 [185]
    1 [186]
    0 [187]
    2 [188]
    3 [189]
    0 [190]
    Units: mL/min
        geometric mean (geometric coefficient of variation)
    ±
    21 ± 99999
    ±
    ±
    8.77 ± 99999
    ±
    48.4 ± 99999
    11.5 ± 99999
    ±
    24.75 ± 88
    55.9 ± 99999
    36.9 ± 99999
    ±
    99999 ± 99999
    69.16 ± 39
    ±
    Notes
    [175] - Results are not reported as none of the subject had PK parameter available in this group.
    [176] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [177] - Results are not reported as none of the subject had PK parameter available in this group.
    [178] - Results are not reported as none of the subject had PK parameter available in this group.
    [179] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [180] - Results are not reported as none of the subject had PK parameter available in this group.
    [181] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [182] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [183] - Results are not reported as none of the subject had PK parameter available in this group.
    [184] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [185] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [186] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [187] - Results are not reported as none of the subject had PK parameter available in this group.
    [188] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [189] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [190] - Results are not reported as none of the subject had PK parameter available in this group.
    No statistical analyses for this end point

    Secondary: Renal Clearance (CLr): Single-Dose Analysis

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    End point title
    Renal Clearance (CLr): Single-Dose Analysis
    End point description
    Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for subjects who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose subjects). PK parameter analysis population. Results are only reported for pregabalin 15 mg/kg/day, 7 to 11 years and pregabalin 5 mg/kg/day, 12 to 16 years because none of the subject had PK parameter available in rest of the groups. For number of subjects analyzed= 1, 99999 was reported in place of geometric CV as it was not evaluated.
    End point type
    Secondary
    End point timeframe
    0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
    End point values
    Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)
    Number of subjects analysed
    0 [191]
    0 [192]
    0 [193]
    0 [194]
    0 [195]
    0 [196]
    0 [197]
    0 [198]
    0 [199]
    0 [200]
    0 [201]
    1 [202]
    0 [203]
    1 [204]
    0 [205]
    0 [206]
    Units: mL/min
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    42.6 ± 99999
    ±
    73.8 ± 99999
    ±
    ±
    Notes
    [191] - Results are not reported as none of the subject had PK parameter available in this group.
    [192] - Results are not reported as none of the subject had PK parameter available in this group.
    [193] - Results are not reported as none of the subject had PK parameter available in this group.
    [194] - Results are not reported as none of the subject had PK parameter available in this group.
    [195] - Results are not reported as none of the subject had PK parameter available in this group.
    [196] - Results are not reported as none of the subject had PK parameter available in this group.
    [197] - Results are not reported as none of the subject had PK parameter available in this group.
    [198] - Results are not reported as none of the subject had PK parameter available in this group.
    [199] - Results are not reported as none of the subject had PK parameter available in this group.
    [200] - Results are not reported as none of the subject had PK parameter available in this group.
    [201] - Results are not reported as none of the subject had PK parameter available in this group.
    [202] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [203] - Results are not reported as none of the subject had PK parameter available in this group.
    [204] - 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    [205] - Results are not reported as none of the subject had PK parameter available in this group.
    [206] - Results are not reported as none of the subject had PK parameter available in this group.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AE) (serious and nonserious) were to be recorded from the time the subject provided consent to participate in the study through the last subject visit.
    Adverse event reporting additional description
    The same event may appear as both an AE and a serious adverse event(SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Latest coding was used to generate AEs tables.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation as double blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administerd. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 1 to 23 Months)
    Reporting group description
    Subjects of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 2 to 6 Years)
    Reporting group description
    Subjects of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation of different doses were administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was aadministered .Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral capsule as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received pregabalin oral capsule as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 7 to 11 Years)
    Reporting group description
    Subjects of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral liquid formulation as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral capsule as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received pregabalin oral capsule as double-blind treatment. Single open-label morning dose of pregabalin oral capsule was administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Reporting group title
    Placebo (Age Cohort: 12 to 16 Years)
    Reporting group description
    Subjects of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation or pregabalin oral capsule of different doses were administered. Subjects who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

    Serious adverse events
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Placebo (Age Cohort: 1 to 23 Months) Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Placebo (Age Cohort: 2 to 6 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Placebo (Age Cohort: 7 to 11 Years) Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Placebo (Age Cohort: 12 to 16 Years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    3 / 3 (100.00%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    4 / 5 (80.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    2 / 2 (100.00%)
    2 / 3 (66.67%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    0 / 3 (0.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Learning disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tandem gait test abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhonchi
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Snoring
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Balance disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Convulsion
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 3 (66.67%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    2
    1
    0
    Drooling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    1
    0
    0
    Hypersomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Mental impairment
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Nystagmus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sedation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    3
    2
    1
    1
    0
    0
    0
    2
    1
    0
    1
    0
    1
    0
    0
    1
    0
    Speech disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Mydriasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2010
    1. Reduction in the number of subjects in the 1 to 23 month age cohorts from 8/dose level to 4/dose level.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Results are reported for AUCtau for multiple-dose PK analysis and AUC (0-∞) for single-dose PK analysis, instead of AUC (0-24), as per change in planned analysis.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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