Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

    Summary
    EudraCT number
    		 2010-020852-79
    Trial protocol
    		 CZ   LT   FI   NL   FR   HU   BE   EE   SE   PL   AT   GR   IT   BG  
    Global end of trial date
    10 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2017
    First version publication date
    16 Feb 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A0081041
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 110017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Aug 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 2 dose levels of pregabalin (Level 1: 2.5 mg/kg/day [maximum 150 mg/day] and Level 2: 10 mg/kg/day [maximum 600 mg/day]) compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 4 to 16 years of age.
    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 Council for 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
    27 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Hungary: 48
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Philippines: 64
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Romania: 27
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    Turkey: 6
    Country: Number of subjects enrolled
    Ukraine: 55
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    295
    EEA total number of subjects
    116
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    173
    Adolescents (12-17 years)
    122
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The subjects for the study were enrolled from 18 countries. The study start date was 29-Sep-2011 and the study completion date was 10-Aug-2016.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day
    Arm description
    		 Subjects aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged 4 to 16 years and < 30 kilograms (kg) in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Arm title
    		 Pregabalin: 10 mg/kg/day or 14 mg/kg/day
    Arm description
    		 Subjects aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged 4 to 16 years and < 30 kilograms (kg) in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Arm title
    		 Placebo
    Arm description
    		 Subjects aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects <30 kg in weight received placebo in the form of oral solution while subjects >=30 kg in weight received placebo in the form of oral solution or capsule.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Started
    104
    97
    94
    Completed
    94
    81
    84
    Not completed
    10
    16
    10
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    1
    2
    2
         Adverse event, non-fatal
    1
    4
    -
         Insufficient Clinical Response
    3
    4
    5
         Protocol deviation
    3
    4
    3
         Other Unspecified
    2
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day
    Reporting group description
    		 Subjects aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Reporting group title
    Pregabalin: 10 mg/kg/day or 14 mg/kg/day
    Reporting group description
    		 Subjects aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects <30 kg in weight received placebo in the form of oral solution while subjects >=30 kg in weight received placebo in the form of oral solution or capsule.

    Reporting group values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo Total
    Number of subjects
    		 104 97 94 295
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 62 59 52 173
        Adolescents (12-17 years)
    		 42 38 42 122
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.2 ± 3.9 10.1 ± 3.5 10.3 ± 3.7 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 52 41 40 133
        Male
    		 52 56 54 162

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day
    Reporting group description
    		 Subjects aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Reporting group title
    Pregabalin: 10 mg/kg/day or 14 mg/kg/day
    Reporting group description
    		 Subjects aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects <30 kg in weight received placebo in the form of oral solution while subjects >=30 kg in weight received placebo in the form of oral solution or capsule.

    Primary: Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase

    		 Close Top of page
    End point title
    		 Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase [1]
    End point description
    All partial onset seizures experienced during baseline phase were recorded by the subjects or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {–} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all subjects to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
    End point type
    Primary
    End point timeframe
    Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
    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: For baseline, Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    93
    Units: Seizures per 28 days
        arithmetic mean (standard deviation)
    3.27 ± 1.215
    3.19 ± 1.269
    3.18 ± 1.302
    No statistical analyses for this end point

    Primary: Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase

    		 Close Top of page
    End point title
    		 Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase
    End point description
    All partial onset seizures experienced during treatment phase were recorded by the subjects or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {–} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all subjects to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
    End point type
    Primary
    End point timeframe
    Day 1 up to Week 12
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    103
    96
    93
    Units: Seizures per 28 days
        least squares mean (standard error)
    2.86 ± 0.07
    2.74 ± 0.072
    2.96 ± 0.073
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.
    Comparison groups
    Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day v Placebo
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2577
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.092
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.
    Comparison groups
    Pregabalin: 10 mg/kg/day or 14 mg/kg/day v Placebo
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0185
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.094

    Secondary: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase

    		 Close Top of page
    End point title
    		 Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase
    End point description
    Percentage of subjects with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {–} number of missing diary days in treatment phase])*28.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 12
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    93
    Units: percentage of subjects
        number (not applicable)
    29.1
    40.6
    22.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.
    Comparison groups
    Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8024
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.528
         upper limit
    		 2.03
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.
    Comparison groups
    Pregabalin: 10 mg/kg/day or 14 mg/kg/day v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0092
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.636
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.851
         upper limit
    		 3.147

    Other pre-specified: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    94
    Units: subjects
        AEs
    67
    68
    56
        SAEs
    5
    10
    7
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    94
    Units: subjects
        AEs
    37
    46
    30
        SAEs
    1
    1
    1
    No statistical analyses for this end point

    Other pre-specified: Number of Adverse Events by Severity

    		 Close Top of page
    End point title
    		 Number of Adverse Events by Severity
    End point description
    An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with subject’s usual function b) moderate: AEs interferes to some extent with subject’s usual function c) severe: AEs interferes significantly with subject’s usual function.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    94
    Units: events
        Mild
    144
    162
    126
        Moderate
    33
    31
    21
        Severe
    7
    3
    5
    No statistical analyses for this end point

    Other pre-specified: Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Subjects Less Than 6 Years of Age

    		 Close Top of page
    End point title
    		 Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Subjects Less Than 6 Years of Age
    End point description
    CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on subject’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a subject T Score was >=68 in any of the sub-scales, the subject was referred for Mental Health Risk Assessment that included assessment of subject continuation to the study. Safety population. N=subjects evaluable for endpoint, n=number of subjects evaluable for specific categories.
    End point type
    Other pre-specified
    End point timeframe
    Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    12
    14
    14
    Units: T scores
    arithmetic mean (standard deviation)
        Week -8 (n= 12, 14, 14)
    48.3 ± 12.12
    55.1 ± 9.37
    54.9 ± 11.15
        Week -4 (n= 12, 14, 14)
    48.1 ± 12.12
    50.9 ± 7.01
    52.6 ± 9.19
        Week 0 (n= 12, 14, 14)
    46.4 ± 14.14
    49.1 ± 7.08
    50.6 ± 9.61
        Week 1 (n= 12, 13, 14)
    46.3 ± 14.47
    48.7 ± 9.36
    50.7 ± 9.47
        Week 2 (n= 11, 13, 13)
    46.5 ± 14.45
    45.6 ± 8.21
    48.3 ± 10.93
        Week 3 (n= 12, 14, 13)
    45.6 ± 13.33
    44.2 ± 9.37
    49.6 ± 10.38
        Week 6 (n= 11, 13, 11)
    45.5 ± 16.73
    42.1 ± 9.65
    47.5 ± 15.19
        Week 9 (n= 11, 13, 11)
    46 ± 15.43
    40.6 ± 10.19
    51 ± 9.81
        Week 12 (n= 11, 14, 13)
    42.1 ± 11.99
    40.8 ± 8.95
    50.5 ± 8.91
        Week 13 (n= 12, 14, 11)
    44.3 ± 13.61
    39.9 ± 7.77
    50.8 ± 10.23
    No statistical analyses for this end point

    Other pre-specified: Child Behaviour Checklist (CBCL): Withdraw Subscale Score in Subjects Less Than 6 Years of Age

    		 Close Top of page
    End point title
    		 Child Behaviour Checklist (CBCL): Withdraw Subscale Score in Subjects Less Than 6 Years of Age
    End point description
    CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on subject’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a subject T Score was >=68 in any of the sub-scales, the subject was referred for Mental Health Risk Assessment that included assessment of subject continuation to the study Safety population. N= subjects evaluable for endpoint, n=number of subjects evaluable for specific categories.
    End point type
    Other pre-specified
    End point timeframe
    Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    12
    14
    14
    Units: T scores
    arithmetic mean (standard deviation)
        Week -8 (n= 12, 14, 14)
    56.4 ± 6.04
    64 ± 10.29
    63.1 ± 10.5
        Week -4 (n= 12, 14, 14)
    55.4 ± 5.43
    61.3 ± 8.99
    61.9 ± 10.48
        Week 0 (n= 12, 14, 14)
    56.6 ± 6.68
    60.6 ± 8.06
    60.9 ± 10.86
        Week 1 (n= 12, 13, 14)
    56.8 ± 7.12
    60.9 ± 10.01
    59.5 ± 10.09
        Week 2 (n= 11, 13, 13)
    56.3 ± 6.17
    60.2 ± 9.32
    59.2 ± 11.61
        Week 3 (n= 12, 14, 13)
    54.8 ± 6.8
    58.6 ± 8.53
    60.8 ± 11.02
        Week 6 (n= 11, 13, 11)
    55.5 ± 8.29
    56.6 ± 5.24
    54.5 ± 20.82
        Week 9 (n= 11, 13, 11)
    56.1 ± 6.99
    57.1 ± 7.3
    60 ± 10.64
        Week 12 (n= 11, 14, 13)
    54 ± 5.48
    57.3 ± 9.53
    59.6 ± 10.11
        Week 13 (n= 12, 14, 11)
    55.1 ± 6.43
    56.1 ± 7.21
    57.9 ± 10.58
    No statistical analyses for this end point

    Other pre-specified: Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Subjects Less Than 6 Years of Age

    		 Close Top of page
    End point title
    		 Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Subjects Less Than 6 Years of Age
    End point description
    CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on subject’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a subject T Score was >=68 in any of the sub-scales, the subject was referred for Mental Health Risk Assessment that included assessment of subject continuation to the study Safety population. N= subjects evaluable for endpoint, n=number of subjects evaluable for specific categories.
    End point type
    Other pre-specified
    End point timeframe
    Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    12
    14
    14
    Units: T scores
    arithmetic mean (standard deviation)
        Week -8 (n= 12, 14, 14)
    48 ± 10.84
    50.7 ± 11.48
    54.1 ± 10.94
        Week -4 (n= 12, 14, 14)
    47.8 ± 11.04
    47 ± 8.36
    52.5 ± 7.35
        Week 0 (n= 12, 14, 14)
    46.9 ± 11.75
    45.2 ± 7.79
    50.1 ± 8.81
        Week 1 (n= 12, 13, 14)
    46 ± 13.65
    43.8 ± 9.77
    50.1 ± 8.4
        Week 2 (n= 11, 13, 13)
    46.5 ± 13.17
    42.1 ± 7.77
    48.9 ± 8.95
        Week 3 (n= 12, 14, 13)
    46.4 ± 12.64
    42.4 ± 9.16
    49.5 ± 9.81
        Week 6 (n= 11, 13, 11)
    46.7 ± 15.25
    38.7 ± 5.95
    50.7 ± 8.86
        Week 9 (n= 11, 13, 11)
    47.6 ± 13.13
    38.4 ± 5.91
    51.2 ± 9.12
        Week 12 (n= 11, 14, 13)
    44.3 ± 11.78
    39 ± 8.94
    50.2 ± 9.28
        Week 13 (n= 12, 14, 11)
    45.5 ± 13.28
    37.9 ± 8.45
    51.6 ± 9.53
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Detection Task

    		 Close Top of page
    End point title
    		 Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Detection Task
    End point description
    CogState battery:computerized test battery assessing cognitive domains through cognition tasks. Test battery presented on computer with external response buttons.In the study,Cogstate battery:2 tasks to measure psychomotor function (detection task);attention (paediatric identification task).Detection task:measure of simple reaction time and provided a valid assessment of psychomotor function in subjects.In this task, a playing card turning face up was presented in the center of the computer screen.As soon this happened, the subject was to press the 'Yes' response key.There was no minimum or maximum scores as it was a time-based assessment.Software measured the speed of accurate responses to each event.In the endpoint,speed of performance of subjects(calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported.Lower scores=better performance.Safety population.N=subjects evaluable for endpoint,n=subjects evaluable for specific categories.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (pre-dose at Day 1), Week 12
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    74
    61
    66
    Units: log10 milliseconds
    arithmetic mean (standard deviation)
        Baseline (n= 68, 56, 60)
    2.71 ± 0.21
    2.72 ± 0.2
    2.7 ± 0.18
        Change At Week 12 (n= 61, 45, 53)
    0 ± 0.12
    -0.03 ± 0.12
    0.01 ± 0.09
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: attention) Tasks

    		 Close Top of page
    End point title
    		 Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: attention) Tasks
    End point description
    CogState battery:computerized test battery assessing cognitive domains through cognition tasks.Test battery was presented on computer with external response buttons.Paediatric identification task:a measure of choice reaction time and valid assessment of visual attention.In this, a playing card turning face up was presented in center of the computer screen.As soon this happened, participant had to decide whether color of card was black or not.If color was black, subject was to press “Yes” response key, otherwise “no”.No minimum/maximum scores as it was a time-based assessment.Software measured speed of accurate responses (correct identification of color) to each event. In this endpoint,speed of performance of subjects to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported.Lower scores=better performance.Safety population.N=subjects evaluable for endpoint,n=subjects evaluable for specific categories.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (pre-dose at Day 1), Week 12
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    74
    61
    66
    Units: log10 milliseconds
    arithmetic mean (standard deviation)
        Baseline (n= 67, 56, 59)
    2.81 ± 0.15
    2.8 ± 0.15
    2.8 ± 0.14
        Change At Week 12 (n= 60, 44, 51)
    0 ± 0.11
    0 ± 0.12
    0 ± 0.1
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Clinically Significant Laboratory Abnormalities

    		 Close Top of page
    End point title
    		 Number of Subjects With Clinically Significant Laboratory Abnormalities
    End point description
    Criteria for abnormality:hematology (hemoglobin, hematocrit, red blood cells count:<0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN);Liver Function(aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);bilirubin:>1.5*ULN;renal function(blood urea nitrogen, creatinine:>1.3*ULN);Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN);Lipids(cholesterol, triglycerides >1.3*ULN);creatine kinase:>2.0*ULN;glucose fasting:<0.6*LLN or >1.5*ULN,urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF.Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN).Safety population.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    102
    95
    93
    Units: subjects
    61
    63
    61
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Vital Signs Abnormalities

    		 Close Top of page
    End point title
    		 Number of Subjects With Vital Signs Abnormalities
    End point description
    Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. Safety population included all randomized subjects who took at least 1 dose of the study drug.Here,"N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    98
    93
    92
    Units: subjects
        Maximum Increase from Baseline in Sitting SBP
    2
    1
    1
        Maximum Increase from Baseline in Sitting DBP
    6
    8
    11
        Maximum Decrease from Baseline in Sitting SBP
    5
    1
    1
        Maximum Decrease from Baseline in Sitting DBP
    15
    6
    10
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Clinically Significant Change From Baseline in Neurological Examinations at Week 13

    		 Close Top of page
    End point title
    		 Number of Subjects With Clinically Significant Change From Baseline in Neurological Examinations at Week 13
    End point description
    Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    94
    Units: subjects
    0
    1
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Electrocardiogram (ECG) Abnormalities

    		 Close Top of page
    End point title
    		 Number of Subjects With Electrocardiogram (ECG) Abnormalities
    End point description
    Criteria for abnormalities in:1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex):>=140 milliseconds (msec);2) The interval between the start of the P wave and the start of the QRS complex,corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval):>=200 msec;3)Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTCF interval):absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec;5) Maximum QTCB interval (Bazett’s correction):450 to< 480 msec,480 to <500 msec,>=500 msec.Only the categories of ECG abnormalities in which subjects were found abnormal, were reported in this endpoint.Safety population =all randomized subjects who took at least 1 dose of the study drug.Here,"N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    102
    97
    94
    Units: subjects
        Maximum PR Interval
    1
    0
    1
        Maximum QTCB Interval (Bazett's Correction)
    2
    0
    2
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Clinically Significant Change From Baseline in Physical Examinations at Week 13

    		 Close Top of page
    End point title
    		 Number of Subjects With Clinically Significant Change From Baseline in Physical Examinations at Week 13
    End point description
    Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator. Safety population included all randomized subjects who took at least 1 dose of the study drug.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    104
    97
    94
    Units: subjects
    5
    5
    2
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline

    		 Close Top of page
    End point title
    		 Number of Subjects (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline
    End point description
    C-SSRS (mapped to C-CASA):subject-rated questionnaire assessing suicidal ideation and suicidal behavior.For suicidal ideation and behaviour,data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7.C-SSRS assessed whether subject experienced following:completed suicide (C-CASA code 1);suicide attempt (response of “Yes” on “actual attempt”)(C-CASA code 2);preparatory acts toward imminent suicidal behavior (ISB)(“Yes” on “preparatory acts or behavior”)(C-CASA code 3);suicidal ideation(“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent) (C-CASA code 4);any self-injurious behavior with no suicidal intent (C-CASA code 7).In this endpoint, number of subjects with positive response (response of “yes”) to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported.Safety population.N= subjects evaluable for endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (4 week prior to Day 1 of treatment)
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    92
    81
    80
    Units: subjects
        Suicide attempt (C-CASA code 2)
    0
    0
    0
        Preparatory acts towards ISB (C-CASA code 3)
    0
    0
    0
        Suicidal ideation (C-CASA code 4)
    0
    0
    0
        Self injurious behavior (C-CASA code 7)
    1
    1
    1
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period

    		 Close Top of page
    End point title
    		 Number of Subjects (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period
    End point description
    C-SSRS (mapped to C-CASA):subject-rated questionnaire assessing suicidal ideation and suicidal behavior.For this,data from C-SSRS mapped to C-CASA codes 1, 2, 3, 4 and 7.C-SSRS assessed whether subject experienced following:completed suicide (C-CASA code 1); suicide attempt (response of “Yes” on “actual attempt”) (C-CASA code 2);preparatory acts toward imminent suicidal behavior (ISB) (“Yes” on “preparatory acts or behavior”)(C-CASA code 3);suicidal ideation(“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4);any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of subjects with positive response (response of “yes”) to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported. Safety population.N=subjects evaluable for endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 up to Week 13
    End point values
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Pregabalin: 10 mg/kg/day or 14 mg/kg/day Placebo
    Number of subjects analysed
    91
    83
    80
    Units: subjects
        Completed suicide (C-CASA code 1)
    0
    0
    0
        Suicide attempt (C-CASA code 2)
    0
    0
    0
        Preparatory acts towards ISB (C-CASA code 3)
    0
    0
    0
        Suicidal ideation (C-CASA code 4)
    1
    0
    1
        Self injurious behavior (C-CASA code 7)
    1
    2
    2
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 1 week after last dose of study drug (Week 13)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day
    Reporting group description
    		 Subjects aged 4 to 16 years and < 30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects <30 kg in weight received placebo in the form of oral solution while subjects >=30 kg in weight received placebo in the form of oral solution or capsule.

    Reporting group title
    Pregabalin: 10 mg/kg/day or 14 mg/kg/day
    Reporting group description
    		 Subjects aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Subjects aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).

    Serious adverse events
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Placebo Pregabalin: 10 mg/kg/day or 14 mg/kg/day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 104 (4.81%)
    7 / 94 (7.45%)
    10 / 97 (10.31%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Skin graft
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Drug withdrawal convulsions
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 94 (3.19%)
    3 / 97 (3.09%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haematemesis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Pregabalin: 2.5 mg/kg/day or 3.5 mg/kg/day Placebo Pregabalin: 10 mg/kg/day or 14 mg/kg/day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 104 (63.46%)
    55 / 94 (58.51%)
    64 / 97 (65.98%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 94 (2.13%)
    3 / 97 (3.09%)
         occurrences all number
    2
    2
    4
    Energy increased
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    6 / 104 (5.77%)
    3 / 94 (3.19%)
    4 / 97 (4.12%)
         occurrences all number
    6
    3
    4
    Feeling abnormal
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Gait disturbance
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    9 / 104 (8.65%)
    7 / 94 (7.45%)
    9 / 97 (9.28%)
         occurrences all number
    10
    8
    10
    Sluggishness
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    0
    9
    Reproductive system and breast disorders
    Breast swelling
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus genital
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Bronchial obstruction
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 104 (0.00%)
    2 / 94 (2.13%)
    2 / 97 (2.06%)
         occurrences all number
    0
    3
    2
    Cough
         subjects affected / exposed
    9 / 104 (8.65%)
    3 / 94 (3.19%)
    2 / 97 (2.06%)
         occurrences all number
    9
    3
    2
    Hypopnoea
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Interstitial lung disease
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    2
    Rhinitis allergic
         subjects affected / exposed
    2 / 104 (1.92%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    2
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    1
    0
    3
    Wheezing
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Aggression
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Agitation
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Disinhibition
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Initial insomnia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    Insomnia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Irritability
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    3 / 97 (3.09%)
         occurrences all number
    1
    1
    3
    Middle insomnia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Mood altered
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Mutism
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Mood swings
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Tic
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Gamma-glutamyl transferase increased
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Heart rate decreased
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    2
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Weight increased
         subjects affected / exposed
    4 / 104 (3.85%)
    4 / 94 (4.26%)
    13 / 97 (13.40%)
         occurrences all number
    4
    4
    13
    White blood cell count increased
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Animal bite
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Contusion
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    2 / 97 (2.06%)
         occurrences all number
    1
    1
    4
    Ear abrasion
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Eye contusion
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    0
    2
    Fall
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 94 (2.13%)
    2 / 97 (2.06%)
         occurrences all number
    1
    2
    5
    Head injury
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Laceration
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Ligament sprain
         subjects affected / exposed
    2 / 104 (1.92%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    2
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Lip injury
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Periorbital haematoma
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    Scar
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Scratch
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 94 (3.19%)
    2 / 97 (2.06%)
         occurrences all number
    2
    3
    2
    Soft tissue injury
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Thermal burn
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Wound
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Balance disorder
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Clonus
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Disturbance in attention
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Dizziness
         subjects affected / exposed
    4 / 104 (3.85%)
    1 / 94 (1.06%)
    3 / 97 (3.09%)
         occurrences all number
    5
    1
    3
    Headache
         subjects affected / exposed
    4 / 104 (3.85%)
    6 / 94 (6.38%)
    7 / 97 (7.22%)
         occurrences all number
    4
    17
    12
    Hypersomnia
         subjects affected / exposed
    2 / 104 (1.92%)
    2 / 94 (2.13%)
    1 / 97 (1.03%)
         occurrences all number
    2
    2
    1
    Lethargy
         subjects affected / exposed
    2 / 104 (1.92%)
    0 / 94 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    2
    0
    2
    Migraine
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Nystagmus
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    2
    1
    1
    Poor quality sleep
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Seizure
         subjects affected / exposed
    6 / 104 (5.77%)
    4 / 94 (4.26%)
    1 / 97 (1.03%)
         occurrences all number
    11
    5
    1
    Somnolence
         subjects affected / exposed
    18 / 104 (17.31%)
    13 / 94 (13.83%)
    25 / 97 (25.77%)
         occurrences all number
    23
    16
    50
    Tunnel vision
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 104 (1.92%)
    0 / 94 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    2
    0
    5
    Eye disorders
    Asthenopia
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Blepharospasm
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Diplopia
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    10
    Eye swelling
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Hypermetropia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Myopia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Visual brightness
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 104 (2.88%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    4
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 104 (0.00%)
    3 / 94 (3.19%)
    0 / 97 (0.00%)
         occurrences all number
    0
    3
    0
    Constipation
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    3 / 97 (3.09%)
         occurrences all number
    1
    1
    3
    Dental caries
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 104 (0.00%)
    4 / 94 (4.26%)
    5 / 97 (5.15%)
         occurrences all number
    0
    4
    6
    Enterocolitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Lip dry
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    3 / 104 (2.88%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    4
    2
    0
    Oral pain
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Retching
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    4 / 97 (4.12%)
         occurrences all number
    1
    0
    19
    Tongue disorder
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth disorder
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth erosion
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 94 (2.13%)
    0 / 97 (0.00%)
         occurrences all number
    1
    2
    0
    Vomiting
         subjects affected / exposed
    5 / 104 (4.81%)
    4 / 94 (4.26%)
    4 / 97 (4.12%)
         occurrences all number
    6
    4
    5
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    0
    3
    Erythema
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    2
    0
    Skin erosion
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Ascariasis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 94 (3.19%)
    2 / 97 (2.06%)
         occurrences all number
    1
    3
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Conjunctivitis viral
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Dermatitis infected
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 104 (0.00%)
    2 / 94 (2.13%)
    0 / 97 (0.00%)
         occurrences all number
    0
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 94 (3.19%)
    0 / 97 (0.00%)
         occurrences all number
    1
    3
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    9 / 104 (8.65%)
    6 / 94 (6.38%)
    7 / 97 (7.22%)
         occurrences all number
    9
    8
    8
    Otitis media
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Parasitic gastroenteritis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    2 / 104 (1.92%)
    2 / 94 (2.13%)
    3 / 97 (3.09%)
         occurrences all number
    2
    3
    3
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pustular
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    2 / 94 (2.13%)
    0 / 97 (0.00%)
         occurrences all number
    0
    3
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    Skin infection
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 94 (2.13%)
    1 / 97 (1.03%)
         occurrences all number
    1
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 104 (9.62%)
    9 / 94 (9.57%)
    8 / 97 (8.25%)
         occurrences all number
    11
    12
    10
    Varicella
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    1
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    Viral infection
         subjects affected / exposed
    2 / 104 (1.92%)
    0 / 94 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    2
    0
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    Dehydration
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 94 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Hyperphagia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 94 (1.06%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Increased appetite
         subjects affected / exposed
    7 / 104 (6.73%)
    4 / 94 (4.26%)
    10 / 97 (10.31%)
         occurrences all number
    7
    4
    10
    Overweight
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 94 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2011
    1- Clarified that mentally or physically handicapped subjects do not have to complete CogState if they are unable.2- Clarified procedure if dose escalation phase not tolerated.3- Clarified that Greek and Cebuano speaking subjects/parents will be excluded. Greek and Cebuano subjects age 6 years and older can be included.4- Added “allergy to pregabalin or excipients…” in exclusion criteria 18.5- On SOA, footnote “d”, added information on need for additional pregnancy tests based upon local regulations.
    16 Mar 2015
    1-Section 3.1 Screening and Baseline: AED changed to anti-epileptic treatments which include VNS; further detail added to diagnostic and risk assessment procedures.2- Section 4.3.1 Contraceptive Guidelines: updated with current standard wording.3- Section 7.2.1 Assessment of Suicidal Ideation: clarifications added.4- Section 9.4 Interim Safety Analysis: added clarifying text regarding E-DMC.5- Protocol Summary: updated, Lyrica approved in 130 countries, considered a PASS study, external DMC added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 13:21:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA