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Trial record 1 of 1 for:    NCT01389596
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A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years (PERIWINKLE)

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ClinicalTrials.gov Identifier: NCT01389596
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : March 21, 2017
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Epilepsy, Partial Seizures
Intervention Drug: Pregabalin add-on therapy
Enrollment 295
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description Participants 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). Participants 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). Participants 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). Participants 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). Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Period Title: Overall Study
Started 104 97 94
Completed 94 81 84
Not Completed 10 16 10
Reason Not Completed
Protocol Violation             3             4             3
Withdrawal by Subject             1             2             2
Insufficient Clinical Response             3             4             5
Adverse Event             1             4             0
Death             0             1             0
Other Unspecified             2             1             0
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo Total
Hide Arm/Group Description Participants 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). Participants 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). Participants 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). Participants 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). Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. Total of all reporting groups
Overall Number of Baseline Participants 104 97 94 295
Hide Baseline Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 97 participants 94 participants 295 participants
10.2  (3.9) 10.1  (3.5) 10.3  (3.7) 10.2  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 97 participants 94 participants 295 participants
Female
52
  50.0%
41
  42.3%
40
  42.6%
133
  45.1%
Male
52
  50.0%
56
  57.7%
54
  57.4%
162
  54.9%
1.Primary Outcome
Title Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase
Hide Description All partial onset seizures experienced during baseline phase were recorded by the participants 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 participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Time Frame Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 93
Mean (Standard Deviation)
Unit of Measure: Seizures per 28 days
3.27  (1.215) 3.19  (1.269) 3.18  (1.302)
2.Primary Outcome
Title Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase
Hide Description All partial onset seizures experienced during treatment phase were recorded by the participants 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 participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Time Frame Day 1 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, "Number of Participants Analyzed (N)" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 103 96 93
Least Squares Mean (Standard Error)
Unit of Measure: Seizures per 28 days
2.86  (0.070) 2.74  (0.072) 2.96  (0.073)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day, Placebo
Comments Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2577
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.29 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.092
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day, Placebo
Comments Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0185
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.41 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.094
Estimation Comments [Not Specified]
3.Secondary Outcome
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
Hide Description Percentage of participants 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.
Time Frame Day 1 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 93
Measure Type: Number
Unit of Measure: percentage of participants
29.1 40.6 22.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day, Placebo
Comments P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8024
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.036
Confidence Interval (2-Sided) 95%
0.528 to 2.030
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day, Placebo
Comments P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.636
Confidence Interval (2-Sided) 95%
0.851 to 3.147
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant 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.
Time Frame Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 94
Measure Type: Number
Unit of Measure: participants
AEs 67 68 56
SAEs 5 10 7
5.Other Pre-specified Outcome
Title Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant 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.
Time Frame Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 94
Measure Type: Number
Unit of Measure: participants
AEs 37 46 30
SAEs 1 1 1
6.Other Pre-specified Outcome
Title Number of Adverse Events by Severity
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
Time Frame Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 94
Measure Type: Number
Unit of Measure: events
Mild 144 162 126
Moderate 33 31 21
Severe 7 3 5
7.Other Pre-specified Outcome
Title Number of Participants (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
Hide Description The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess 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 participant experienced the 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 outcome, number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported.
Time Frame Baseline (4 week prior to Day 1 of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 92 81 80
Measure Type: Number
Unit of Measure: participants
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
8.Other Pre-specified Outcome
Title Number of Participants (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
Hide Description C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess 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 participant experienced the 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 participants 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
Time Frame Day 1 up to Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 91 83 80
Measure Type: Number
Unit of Measure: participants
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
9.Other Pre-specified Outcome
Title Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age
Hide Description CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant'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. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 12 14 14
Mean (Standard Deviation)
Unit of Measure: T scores
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) 46.0  (15.43) 40.6  (10.19) 51.0  (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)
10.Other Pre-specified Outcome
Title Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age
Hide Description CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant'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. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 12 14 14
Mean (Standard Deviation)
Unit of Measure: T scores
Week -8 (n= 12, 14, 14) 56.4  (6.04) 64.0  (10.29) 63.1  (10.50)
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  (6.80) 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  (7.30) 60.0  (10.64)
Week 12 (n= 11, 14, 13) 54.0  (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)
11.Other Pre-specified Outcome
Title Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age
Hide Description CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant'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. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 12 14 14
Mean (Standard Deviation)
Unit of Measure: T scores
Week -8 (n= 12, 14, 14) 48.0  (10.84) 50.7  (11.48) 54.1  (10.94)
Week -4 (n= 12, 14, 14) 47.8  (11.04) 47.0  (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) 46.0  (13.65) 43.8  (9.77) 50.1  (8.40)
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) 39.0  (8.94) 50.2  (9.28)
Week 13 (n= 12, 14, 11) 45.5  (13.28) 37.9  (8.45) 51.6  (9.53)
12.Other Pre-specified Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task
Hide Description CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.
Time Frame Baseline (pre-dose at Day 1), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 74 61 66
Mean (Standard Deviation)
Unit of Measure: log10 milliseconds
Baseline (n= 68, 56, 60) 2.71  (0.21) 2.72  (0.20) 2.70  (0.18)
Change At Week 12 (n= 61, 45, 53) -0.00  (0.12) -0.03  (0.12) 0.01  (0.09)
13.Other Pre-specified Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks
Hide Description CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The 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 task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press "Yes" response key, otherwise "no". There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.
Time Frame Baseline (pre-dose at Day 1), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 74 61 66
Mean (Standard Deviation)
Unit of Measure: log10 milliseconds
Baseline (n= 67, 56, 59) 2.81  (0.15) 2.80  (0.15) 2.80  (0.14)
Change At Week 12 (n= 60, 44, 51) 0.00  (0.11) 0.00  (0.12) 0.00  (0.10)
14.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities
Hide 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).
Time Frame Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 102 95 93
Measure Type: Number
Unit of Measure: participants
61 63 61
15.Other Pre-specified Outcome
Title Number of Participants With Vital Signs Abnormalities
Hide 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.
Time Frame Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 98 93 92
Measure Type: Number
Unit of Measure: participants
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
16.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations
Hide 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.
Time Frame Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 94
Measure Type: Number
Unit of Measure: participants
0 1 0
17.Other Pre-specified Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide Description Criteria for abnormalities in ECG findings: 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 those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure.
Time Frame Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 102 97 94
Measure Type: Number
Unit of Measure: participants
Maximum PR Interval 1 0 1
Maximum QTCB Interval (Bazett's Correction) 2 0 2
18.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13
Hide 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.
Time Frame Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who took at least 1 dose of the study drug.
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description:
Participants 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). Participants 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).
Participants 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). Participants 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).
Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
Overall Number of Participants Analyzed 104 97 94
Measure Type: Number
Unit of Measure: participants
5 5 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Hide Arm/Group Description Participants 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). Participants 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). Participants 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). Participants 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). Participants 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). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
All-Cause Mortality
Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/104 (4.81%)   10/97 (10.31%)   7/94 (7.45%) 
Blood and lymphatic system disorders       
Lymphadenitis * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Gastrointestinal disorders       
Haematemesis * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Vomiting * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Infections and infestations       
Bronchitis * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Gastroenteritis * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Pneumonia * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Pneumonia bacterial * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Respiratory tract infection viral * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Viral infection * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Injury, poisoning and procedural complications       
Thermal burn * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Nervous system disorders       
Drug withdrawal convulsions * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Epilepsy * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Partial seizures * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Seizure * 1  1/104 (0.96%)  3/97 (3.09%)  3/94 (3.19%) 
Psychiatric disorders       
Hallucination * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Pulmonary oedema * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Surgical and medical procedures       
Skin graft * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/104 (63.46%)   64/97 (65.98%)   55/94 (58.51%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Lymphadenitis * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Cardiac disorders       
Atrioventricular block first degree * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Ear and labyrinth disorders       
Vertigo * 1  2/104 (1.92%)  3/97 (3.09%)  0/94 (0.00%) 
Eye disorders       
Asthenopia * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Blepharospasm * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Diplopia * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Eye swelling * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Hypermetropia * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Myopia * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Vision blurred * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Visual brightness * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Visual impairment * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  3/104 (2.88%)  0/97 (0.00%)  1/94 (1.06%) 
Abdominal pain upper * 1  0/104 (0.00%)  0/97 (0.00%)  3/94 (3.19%) 
Constipation * 1  1/104 (0.96%)  3/97 (3.09%)  1/94 (1.06%) 
Dental caries * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Diarrhoea * 1  0/104 (0.00%)  5/97 (5.15%)  4/94 (4.26%) 
Enterocolitis * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Flatulence * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Haemorrhoids * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Lip dry * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Nausea * 1  3/104 (2.88%)  0/97 (0.00%)  1/94 (1.06%) 
Oral pain * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Retching * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Salivary hypersecretion * 1  1/104 (0.96%)  4/97 (4.12%)  0/94 (0.00%) 
Tongue disorder * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Tooth disorder * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Tooth erosion * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Toothache * 1  1/104 (0.96%)  0/97 (0.00%)  2/94 (2.13%) 
Vomiting * 1  5/104 (4.81%)  4/97 (4.12%)  4/94 (4.26%) 
General disorders       
Asthenia * 1  1/104 (0.96%)  3/97 (3.09%)  2/94 (2.13%) 
Energy increased * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Fatigue * 1  6/104 (5.77%)  4/97 (4.12%)  3/94 (3.19%) 
Feeling abnormal * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Feeling hot * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Gait disturbance * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Malaise * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Pyrexia * 1  9/104 (8.65%)  9/97 (9.28%)  7/94 (7.45%) 
Sluggishness * 1  0/104 (0.00%)  2/97 (2.06%)  0/94 (0.00%) 
Infections and infestations       
Ascariasis * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Bronchitis * 1  1/104 (0.96%)  2/97 (2.06%)  3/94 (3.19%) 
Conjunctivitis * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Conjunctivitis viral * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Cystitis * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Dermatitis infected * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Ear infection * 1  0/104 (0.00%)  0/97 (0.00%)  2/94 (2.13%) 
Gastroenteritis * 1  1/104 (0.96%)  0/97 (0.00%)  3/94 (3.19%) 
Gastroenteritis viral * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Gastrointestinal candidiasis * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Gastrointestinal viral infection * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Nasopharyngitis * 1  9/104 (8.65%)  7/97 (7.22%)  6/94 (6.38%) 
Otitis media * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Parasitic gastroenteritis * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Pharyngitis * 1  2/104 (1.92%)  3/97 (3.09%)  2/94 (2.13%) 
Pharyngotonsillitis * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Pneumonia * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Rash pustular * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Respiratory tract infection * 1  0/104 (0.00%)  0/97 (0.00%)  2/94 (2.13%) 
Respiratory tract infection viral * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Rhinitis * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Sinusitis * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Skin infection * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Tonsillitis * 1  1/104 (0.96%)  1/97 (1.03%)  2/94 (2.13%) 
Upper respiratory tract infection * 1  10/104 (9.62%)  8/97 (8.25%)  9/94 (9.57%) 
Urinary tract infection * 1  1/104 (0.96%)  1/97 (1.03%)  1/94 (1.06%) 
Varicella * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Viral infection * 1  2/104 (1.92%)  3/97 (3.09%)  0/94 (0.00%) 
Viral upper respiratory tract infection * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Injury, poisoning and procedural complications       
Animal bite * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Clavicle fracture * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Contusion * 1  1/104 (0.96%)  2/97 (2.06%)  1/94 (1.06%) 
Ear abrasion * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Eye contusion * 1  0/104 (0.00%)  2/97 (2.06%)  0/94 (0.00%) 
Fall * 1  1/104 (0.96%)  2/97 (2.06%)  2/94 (2.13%) 
Head injury * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Laceration * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Ligament sprain * 1  2/104 (1.92%)  0/97 (0.00%)  0/94 (0.00%) 
Limb injury * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Lip injury * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Periorbital haematoma * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Scar * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Scratch * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Skin abrasion * 1  1/104 (0.96%)  2/97 (2.06%)  3/94 (3.19%) 
Soft tissue injury * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Thermal burn * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Wound * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Investigations       
Body temperature increased * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Gamma-glutamyl transferase increased * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Heart rate decreased * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Hepatic enzyme increased * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Weight increased * 1  4/104 (3.85%)  13/97 (13.40%)  4/94 (4.26%) 
White blood cell count increased * 1  0/104 (0.00%)  0/97 (0.00%)  0/94 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Dehydration * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Hyperphagia * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Hyponatraemia * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Increased appetite * 1  7/104 (6.73%)  10/97 (10.31%)  4/94 (4.26%) 
Overweight * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Myalgia * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Nervous system disorders       
Aphasia * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Balance disorder * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Clonus * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Disturbance in attention * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Dizziness * 1  4/104 (3.85%)  3/97 (3.09%)  1/94 (1.06%) 
Headache * 1  4/104 (3.85%)  7/97 (7.22%)  6/94 (6.38%) 
Hypersomnia * 1  2/104 (1.92%)  1/97 (1.03%)  2/94 (2.13%) 
Lethargy * 1  2/104 (1.92%)  2/97 (2.06%)  0/94 (0.00%) 
Migraine * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Nystagmus * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Partial seizures with secondary generalisation * 1  1/104 (0.96%)  1/97 (1.03%)  1/94 (1.06%) 
Poor quality sleep * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Psychomotor hyperactivity * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Seizure * 1  6/104 (5.77%)  1/97 (1.03%)  4/94 (4.26%) 
Somnolence * 1  18/104 (17.31%)  25/97 (25.77%)  13/94 (13.83%) 
Tunnel vision * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Psychiatric disorders       
Abnormal behaviour * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Aggression * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Agitation * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Disinhibition * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Initial insomnia * 1  0/104 (0.00%)  1/97 (1.03%)  1/94 (1.06%) 
Insomnia * 1  1/104 (0.96%)  1/97 (1.03%)  0/94 (0.00%) 
Irritability * 1  1/104 (0.96%)  3/97 (3.09%)  1/94 (1.06%) 
Middle insomnia * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Mood altered * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Mood swings * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Mutism * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Nervousness * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Sleep disorder * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Tic * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Renal and urinary disorders       
Urinary retention * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Reproductive system and breast disorders       
Breast swelling * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Pruritus genital * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Bronchial obstruction * 1  0/104 (0.00%)  0/97 (0.00%)  1/94 (1.06%) 
Cough * 1  9/104 (8.65%)  2/97 (2.06%)  3/94 (3.19%) 
Epistaxis * 1  0/104 (0.00%)  2/97 (2.06%)  2/94 (2.13%) 
Hypopnoea * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
Interstitial lung disease * 1  1/104 (0.96%)  0/97 (0.00%)  1/94 (1.06%) 
Nasal congestion * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Oropharyngeal pain * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Rhinitis allergic * 1  2/104 (1.92%)  0/97 (0.00%)  1/94 (1.06%) 
Rhinorrhoea * 1  1/104 (0.96%)  2/97 (2.06%)  0/94 (0.00%) 
Wheezing * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Skin and subcutaneous tissue disorders       
Eczema * 1  0/104 (0.00%)  2/97 (2.06%)  0/94 (0.00%) 
Erythema * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Rash * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Rash erythematous * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Rash maculo-papular * 1  0/104 (0.00%)  0/97 (0.00%)  0/94 (0.00%) 
Skin erosion * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Vascular disorders       
Haematoma * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Hypertension * 1  0/104 (0.00%)  1/97 (1.03%)  0/94 (0.00%) 
Hypotension * 1  1/104 (0.96%)  0/97 (0.00%)  0/94 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
ClinicalTrials.gov Identifier: NCT01389596    
Other Study ID Numbers: A0081041
2010-020852-79 ( EudraCT Number )
XALCORY 1014 ( Other Identifier: Alias Study Number )
First Submitted: July 6, 2011
First Posted: July 8, 2011
Results First Submitted: January 31, 2017
Results First Posted: March 21, 2017
Last Update Posted: January 20, 2021