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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

A0081074

ISRCTN number

US NCT number

NCT00437281

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

11 Apr 2013

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Nov 2012

Was the trial ended prematurely?

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

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Korea, Republic of: 3

Country: Number of subjects enrolled

United States: 58

Country: Number of subjects enrolled

Mexico: 4

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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 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

Are arms mutually exclusive

Yes

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.

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.

Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)

Arm description

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.

Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)

Arm description

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.

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.

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.

Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)

Arm description

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.

Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)

Arm description

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.

Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)

Arm description

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.

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.

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.

Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)

Arm description

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.

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.

Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)

Arm description

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.

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.

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.

Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)

Arm description

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.

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.

Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)

Arm description

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.

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

Top of page

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)

Reporting group description

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

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)

Reporting group description

Reporting group title

Placebo (Age Cohort: 1 to 23 Months)

Reporting group description

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Placebo (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Placebo (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Placebo (Age Cohort: 12 to 16 Years)

Reporting group description

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

Top of page

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)

Reporting group description

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

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)

Reporting group description

Reporting group title

Placebo (Age Cohort: 1 to 23 Months)

Reporting group description

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Placebo (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Placebo (Age Cohort: 7 to 11 Years)

Reporting group description

Reporting group title

Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)

Reporting group description

Reporting group title

Placebo (Age Cohort: 12 to 16 Years)

Reporting group description

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

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.

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 )

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

Top of page

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

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

Top of page

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.

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 )

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

Top of page

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

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

Top of page

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.

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

Top of page

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

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 ^[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)

1.98 (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 )

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

Top of page

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.

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 )

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

Top of page

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

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

Top of page

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.

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 )

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

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.

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

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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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 name

MedDRA

Dictionary version

17.1

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

Reporting group title

Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

Reporting group title

Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)

Reporting group description

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

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

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

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.

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 / 4 (0.00%)

0 / 3 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

1 / 3 (33.33%)

1 / 5 (20.00%)

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Nervous system disorders

Ataxia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

1 / 3 (33.33%)

0 / 5 (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

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Convulsion

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

1 / 5 (20.00%)

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 2 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Somnolence

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 5 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

1 / 3 (33.33%)

0 / 5 (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

1 / 1

0 / 0

deaths causally related to treatment / all

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
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
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
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
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
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
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
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

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Were there any global substantial amendments to the protocol? Yes

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.

Were there any global interruptions to the trial? No

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.

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

Secondary: 28-Day Seizure Frequency Rate

Secondary: 28-Day Seizure Frequency Rate

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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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