Trial Outcomes & Findings for A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years (NCT NCT01389596)

NCT ID: NCT01389596

Last Updated: 2021-01-20

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 295 participants
• Primary outcome timeframe: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
• Results posted on: 2021-01-20

Participant Flow

Participant milestones

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day 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).	Placebo 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 Study STARTED	104	97	94
Overall Study COMPLETED	94	81	84
Overall Study NOT COMPLETED	10	16	10

Reasons for withdrawal

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day 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).	Placebo 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 Study Protocol Violation	3	4	3
Overall Study Withdrawal by Subject	1	2	2
Overall Study Insufficient Clinical Response	3	4	5
Overall Study Adverse Event	1	4	0
Overall Study Death	0	1	0
Overall Study Other Unspecified	2	1	0

Baseline Characteristics

A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

Baseline characteristics by cohort

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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 n=295 Participants Total of all reporting groups
Age, Continuous	10.2 years STANDARD_DEVIATION 3.9 • n=5 Participants	10.1 years STANDARD_DEVIATION 3.5 • n=7 Participants	10.3 years STANDARD_DEVIATION 3.7 • n=5 Participants	10.2 years STANDARD_DEVIATION 3.7 • n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	41 Participants n=7 Participants	40 Participants n=5 Participants	133 Participants n=4 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	56 Participants n=7 Participants	54 Participants n=5 Participants	162 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])

Population: 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.

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).

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=93 Participants 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.
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase	3.27 Seizures per 28 days Standard Deviation 1.215	3.19 Seizures per 28 days Standard Deviation 1.269	3.18 Seizures per 28 days Standard Deviation 1.302

PRIMARY outcome

Timeframe: Day 1 up to Week 12

Population: 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.

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).

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=103 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=96 Participants 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).	Placebo n=93 Participants 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.
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase	2.86 Seizures per 28 days Standard Error 0.070	2.74 Seizures per 28 days Standard Error 0.072	2.96 Seizures per 28 days Standard Error 0.073

SECONDARY outcome

Timeframe: Day 1 up to Week 12

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=93 Participants 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.
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase	29.1 percentage of participants	40.6 percentage of participants	22.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)

Population: Safety population included all randomized participants who took at least 1 dose of the study drug.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	5 participants	10 participants	7 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	67 participants	68 participants	56 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)

Population: Safety population included all randomized participants who took at least 1 dose of the study drug.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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.
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	37 participants	46 participants	30 participants
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 participants	1 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)

Population: Safety population included all randomized participants who took at least 1 dose of the study drug.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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.
Number of Adverse Events by Severity Mild	144 events	162 events	126 events
Number of Adverse Events by Severity Moderate	33 events	31 events	21 events
Number of Adverse Events by Severity Severe	7 events	3 events	5 events

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (4 week prior to Day 1 of treatment)

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=92 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=81 Participants 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).	Placebo n=80 Participants 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.
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 Suicide attempt (C-CASA code 2)	0 participants	0 participants	0 participants
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 Suicidal ideation (C-CASA code 4)	0 participants	0 participants	0 participants
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 Preparatory acts towards ISB (C-CASA code 3)	0 participants	0 participants	0 participants
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 Self injurious behavior (C-CASA code 7)	1 participants	1 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Week 13

Population: 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.

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

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=91 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=83 Participants 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).	Placebo n=80 Participants 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.
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 Suicide attempt (C-CASA code 2)	0 participants	0 participants	0 participants
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 Preparatory acts towards ISB (C-CASA code 3)	0 participants	0 participants	0 participants
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 Completed suicide (C-CASA code 1)	0 participants	0 participants	0 participants
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 Suicidal ideation (C-CASA code 4)	1 participants	0 participants	1 participants
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 Self injurious behavior (C-CASA code 7)	1 participants	2 participants	2 participants

OTHER_PRE_SPECIFIED outcome

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)

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=12 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=14 Participants 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).	Placebo n=14 Participants 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.
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week -8 (n= 12, 14, 14)	48.3 T scores Standard Deviation 12.12	55.1 T scores Standard Deviation 9.37	54.9 T scores Standard Deviation 11.15
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 2 (n= 11, 13, 13)	46.5 T scores Standard Deviation 14.45	45.6 T scores Standard Deviation 8.21	48.3 T scores Standard Deviation 10.93
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week -4 (n= 12, 14, 14)	48.1 T scores Standard Deviation 12.12	50.9 T scores Standard Deviation 7.01	52.6 T scores Standard Deviation 9.19
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 0 (n= 12, 14, 14)	46.4 T scores Standard Deviation 14.14	49.1 T scores Standard Deviation 7.08	50.6 T scores Standard Deviation 9.61
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 1 (n= 12, 13, 14)	46.3 T scores Standard Deviation 14.47	48.7 T scores Standard Deviation 9.36	50.7 T scores Standard Deviation 9.47
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 3 (n= 12, 14, 13)	45.6 T scores Standard Deviation 13.33	44.2 T scores Standard Deviation 9.37	49.6 T scores Standard Deviation 10.38
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 6 (n= 11, 13, 11)	45.5 T scores Standard Deviation 16.73	42.1 T scores Standard Deviation 9.65	47.5 T scores Standard Deviation 15.19
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 9 (n= 11, 13, 11)	46.0 T scores Standard Deviation 15.43	40.6 T scores Standard Deviation 10.19	51.0 T scores Standard Deviation 9.81
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 12 (n= 11, 14, 13)	42.1 T scores Standard Deviation 11.99	40.8 T scores Standard Deviation 8.95	50.5 T scores Standard Deviation 8.91
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age Week 13 (n= 12, 14, 11)	44.3 T scores Standard Deviation 13.61	39.9 T scores Standard Deviation 7.77	50.8 T scores Standard Deviation 10.23

OTHER_PRE_SPECIFIED outcome

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)

Population: 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.

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

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=12 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=14 Participants 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).	Placebo n=14 Participants 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.
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week -4 (n= 12, 14, 14)	55.4 T scores Standard Deviation 5.43	61.3 T scores Standard Deviation 8.99	61.9 T scores Standard Deviation 10.48
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week -8 (n= 12, 14, 14)	56.4 T scores Standard Deviation 6.04	64.0 T scores Standard Deviation 10.29	63.1 T scores Standard Deviation 10.50
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 0 (n= 12, 14, 14)	56.6 T scores Standard Deviation 6.68	60.6 T scores Standard Deviation 8.06	60.9 T scores Standard Deviation 10.86
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 1 (n= 12, 13, 14)	56.8 T scores Standard Deviation 7.12	60.9 T scores Standard Deviation 10.01	59.5 T scores Standard Deviation 10.09
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 2 (n= 11, 13, 13)	56.3 T scores Standard Deviation 6.17	60.2 T scores Standard Deviation 9.32	59.2 T scores Standard Deviation 11.61
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 3 (n= 12, 14, 13)	54.8 T scores Standard Deviation 6.80	58.6 T scores Standard Deviation 8.53	60.8 T scores Standard Deviation 11.02
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 6 (n= 11, 13, 11)	55.5 T scores Standard Deviation 8.29	56.6 T scores Standard Deviation 5.24	54.5 T scores Standard Deviation 20.82
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 9 (n= 11, 13, 11)	56.1 T scores Standard Deviation 6.99	57.1 T scores Standard Deviation 7.30	60.0 T scores Standard Deviation 10.64
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 12 (n= 11, 14, 13)	54.0 T scores Standard Deviation 5.48	57.3 T scores Standard Deviation 9.53	59.6 T scores Standard Deviation 10.11
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age Week 13 (n= 12, 14, 11)	55.1 T scores Standard Deviation 6.43	56.1 T scores Standard Deviation 7.21	57.9 T scores Standard Deviation 10.58

OTHER_PRE_SPECIFIED outcome

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)

Population: 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.

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

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=12 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=14 Participants 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).	Placebo n=14 Participants 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.
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week -4 (n= 12, 14, 14)	47.8 T scores Standard Deviation 11.04	47.0 T scores Standard Deviation 8.36	52.5 T scores Standard Deviation 7.35
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 0 (n= 12, 14, 14)	46.9 T scores Standard Deviation 11.75	45.2 T scores Standard Deviation 7.79	50.1 T scores Standard Deviation 8.81
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week -8 (n= 12, 14, 14)	48.0 T scores Standard Deviation 10.84	50.7 T scores Standard Deviation 11.48	54.1 T scores Standard Deviation 10.94
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 1 (n= 12, 13, 14)	46.0 T scores Standard Deviation 13.65	43.8 T scores Standard Deviation 9.77	50.1 T scores Standard Deviation 8.40
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 2 (n= 11, 13, 13)	46.5 T scores Standard Deviation 13.17	42.1 T scores Standard Deviation 7.77	48.9 T scores Standard Deviation 8.95
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 3 (n= 12, 14, 13)	46.4 T scores Standard Deviation 12.64	42.4 T scores Standard Deviation 9.16	49.5 T scores Standard Deviation 9.81
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 6 (n= 11, 13, 11)	46.7 T scores Standard Deviation 15.25	38.7 T scores Standard Deviation 5.95	50.7 T scores Standard Deviation 8.86
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 9 (n= 11, 13, 11)	47.6 T scores Standard Deviation 13.13	38.4 T scores Standard Deviation 5.91	51.2 T scores Standard Deviation 9.12
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 12 (n= 11, 14, 13)	44.3 T scores Standard Deviation 11.78	39.0 T scores Standard Deviation 8.94	50.2 T scores Standard Deviation 9.28
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age Week 13 (n= 12, 14, 11)	45.5 T scores Standard Deviation 13.28	37.9 T scores Standard Deviation 8.45	51.6 T scores Standard Deviation 9.53

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose at Day 1), Week 12

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=74 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=61 Participants 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).	Placebo n=66 Participants 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.
Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task Baseline (n= 68, 56, 60)	2.71 log10 milliseconds Standard Deviation 0.21	2.72 log10 milliseconds Standard Deviation 0.20	2.70 log10 milliseconds Standard Deviation 0.18
Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task Change At Week 12 (n= 61, 45, 53)	-0.00 log10 milliseconds Standard Deviation 0.12	-0.03 log10 milliseconds Standard Deviation 0.12	0.01 log10 milliseconds Standard Deviation 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose at Day 1), Week 12

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=74 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=61 Participants 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).	Placebo n=66 Participants 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.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks Baseline (n= 67, 56, 59)	2.81 log10 milliseconds Standard Deviation 0.15	2.80 log10 milliseconds Standard Deviation 0.15	2.80 log10 milliseconds Standard Deviation 0.14
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks Change At Week 12 (n= 60, 44, 51)	0.00 log10 milliseconds Standard Deviation 0.11	0.00 log10 milliseconds Standard Deviation 0.12	0.00 log10 milliseconds Standard Deviation 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

Population: 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.

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).

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=102 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=95 Participants 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).	Placebo n=93 Participants 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.
Number of Participants With Clinically Significant Laboratory Abnormalities	61 participants	63 participants	61 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=98 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=93 Participants 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).	Placebo n=92 Participants 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.
Number of Participants With Vital Signs Abnormalities Maximum Increase from Baseline in Sitting SBP	2 participants	1 participants	1 participants
Number of Participants With Vital Signs Abnormalities Maximum Increase from Baseline in Sitting DBP	6 participants	8 participants	11 participants
Number of Participants With Vital Signs Abnormalities Maximum Decrease from Baseline in Sitting SBP	5 participants	1 participants	1 participants
Number of Participants With Vital Signs Abnormalities Maximum Decrease from Baseline in Sitting DBP	15 participants	6 participants	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

Population: Safety population included all randomized participants who took at least 1 dose of the study drug.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations	0 participants	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

Population: 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.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=102 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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.
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum PR Interval	1 participants	0 participants	1 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTCB Interval (Bazett's Correction)	2 participants	0 participants	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

Population: Safety population included all randomized participants who took at least 1 dose of the study drug.

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.

Outcome measures

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 Participants 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 Participants 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).	Placebo n=94 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13	5 participants	5 participants	2 participants

Adverse Events

Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day

Serious events: 5 serious events

Other events: 66 other events

Deaths: 0 deaths

Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day

Serious events: 10 serious events

Other events: 64 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 participants at risk 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 participants at risk 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).	Placebo n=94 participants at risk 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.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/104	1.0% 1/97	0.00% 0/94
Gastrointestinal disorders Haematemesis	0.00% 0/104	1.0% 1/97	0.00% 0/94
Gastrointestinal disorders Vomiting	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Bronchitis	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Gastroenteritis	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Pneumonia	0.00% 0/104	1.0% 1/97	1.1% 1/94
Infections and infestations Pneumonia bacterial	0.96% 1/104	0.00% 0/97	0.00% 0/94
Infections and infestations Respiratory tract infection viral	0.00% 0/104	0.00% 0/97	1.1% 1/94
Infections and infestations Viral infection	0.00% 0/104	0.00% 0/97	1.1% 1/94
Injury, poisoning and procedural complications Thermal burn	0.96% 1/104	0.00% 0/97	0.00% 0/94
Metabolism and nutrition disorders Dehydration	0.00% 0/104	0.00% 0/97	1.1% 1/94
Nervous system disorders Drug withdrawal convulsions	0.00% 0/104	0.00% 0/97	1.1% 1/94
Nervous system disorders Epilepsy	0.00% 0/104	1.0% 1/97	0.00% 0/94
Nervous system disorders Partial seizures	0.96% 1/104	0.00% 0/97	0.00% 0/94
Nervous system disorders Seizure	0.96% 1/104	3.1% 3/97	3.2% 3/94
Psychiatric disorders Hallucination	0.96% 1/104	0.00% 0/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/104	1.0% 1/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/104	1.0% 1/97	0.00% 0/94
Surgical and medical procedures Skin graft	0.96% 1/104	0.00% 0/97	0.00% 0/94

Other adverse events

Measure	Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day n=104 participants at risk 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).	Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day n=97 participants at risk 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).	Placebo n=94 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/104	1.0% 1/97	0.00% 0/94
Skin and subcutaneous tissue disorders Eczema	0.00% 0/104	2.1% 2/97	0.00% 0/94
Skin and subcutaneous tissue disorders Erythema	0.00% 0/104	1.0% 1/97	0.00% 0/94
Skin and subcutaneous tissue disorders Rash	0.00% 0/104	1.0% 1/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.96% 1/104	2.1% 2/97	0.00% 0/94
Blood and lymphatic system disorders Anaemia	0.96% 1/104	0.00% 0/97	0.00% 0/94
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/104	0.00% 0/97	1.1% 1/94
Cardiac disorders Atrioventricular block first degree	0.00% 0/104	0.00% 0/97	1.1% 1/94
Ear and labyrinth disorders Vertigo	1.9% 2/104	3.1% 3/97	0.00% 0/94
Eye disorders Asthenopia	0.00% 0/104	1.0% 1/97	0.00% 0/94
Eye disorders Blepharospasm	0.96% 1/104	0.00% 0/97	0.00% 0/94
Eye disorders Diplopia	0.00% 0/104	1.0% 1/97	0.00% 0/94
Eye disorders Eye swelling	0.00% 0/104	1.0% 1/97	0.00% 0/94
Eye disorders Hypermetropia	0.00% 0/104	0.00% 0/97	1.1% 1/94
Eye disorders Myopia	0.96% 1/104	0.00% 0/97	0.00% 0/94
Eye disorders Vision blurred	0.96% 1/104	0.00% 0/97	0.00% 0/94
Eye disorders Visual brightness	0.96% 1/104	0.00% 0/97	0.00% 0/94
Eye disorders Visual impairment	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Abdominal pain	2.9% 3/104	0.00% 0/97	1.1% 1/94
Gastrointestinal disorders Abdominal pain upper	0.00% 0/104	0.00% 0/97	3.2% 3/94
Gastrointestinal disorders Constipation	0.96% 1/104	3.1% 3/97	1.1% 1/94
Gastrointestinal disorders Dental caries	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Diarrhoea	0.00% 0/104	5.2% 5/97	4.3% 4/94
Gastrointestinal disorders Enterocolitis	0.00% 0/104	0.00% 0/97	1.1% 1/94
Gastrointestinal disorders Flatulence	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Haemorrhoids	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Lip dry	0.00% 0/104	0.00% 0/97	1.1% 1/94
Gastrointestinal disorders Nausea	2.9% 3/104	0.00% 0/97	1.1% 1/94
Gastrointestinal disorders Oral pain	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Retching	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Salivary hypersecretion	0.96% 1/104	4.1% 4/97	0.00% 0/94
Gastrointestinal disorders Tongue disorder	0.00% 0/104	0.00% 0/97	1.1% 1/94
Gastrointestinal disorders Tooth disorder	0.96% 1/104	0.00% 0/97	0.00% 0/94
Gastrointestinal disorders Tooth erosion	0.00% 0/104	1.0% 1/97	0.00% 0/94
Gastrointestinal disorders Toothache	0.96% 1/104	0.00% 0/97	2.1% 2/94
Gastrointestinal disorders Vomiting	4.8% 5/104	4.1% 4/97	4.3% 4/94
General disorders Asthenia	0.96% 1/104	3.1% 3/97	2.1% 2/94
General disorders Energy increased	0.96% 1/104	0.00% 0/97	0.00% 0/94
General disorders Fatigue	5.8% 6/104	4.1% 4/97	3.2% 3/94
General disorders Feeling abnormal	0.00% 0/104	1.0% 1/97	0.00% 0/94
General disorders Feeling hot	0.00% 0/104	1.0% 1/97	0.00% 0/94
General disorders Gait disturbance	0.00% 0/104	1.0% 1/97	0.00% 0/94
General disorders Malaise	0.00% 0/104	1.0% 1/97	1.1% 1/94
General disorders Pyrexia	8.7% 9/104	9.3% 9/97	7.4% 7/94
General disorders Sluggishness	0.00% 0/104	2.1% 2/97	0.00% 0/94
Infections and infestations Ascariasis	0.00% 0/104	0.00% 0/97	1.1% 1/94
Infections and infestations Bronchitis	0.96% 1/104	2.1% 2/97	3.2% 3/94
Infections and infestations Conjunctivitis	0.96% 1/104	1.0% 1/97	0.00% 0/94
Infections and infestations Conjunctivitis viral	0.00% 0/104	0.00% 0/97	1.1% 1/94
Infections and infestations Cystitis	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Dermatitis infected	0.96% 1/104	0.00% 0/97	0.00% 0/94
Infections and infestations Ear infection	0.00% 0/104	0.00% 0/97	2.1% 2/94
Infections and infestations Gastroenteritis	0.96% 1/104	0.00% 0/97	3.2% 3/94
Infections and infestations Gastroenteritis viral	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Gastrointestinal candidiasis	0.96% 1/104	0.00% 0/97	0.00% 0/94
Infections and infestations Gastrointestinal viral infection	0.96% 1/104	0.00% 0/97	1.1% 1/94
Infections and infestations Nasopharyngitis	8.7% 9/104	7.2% 7/97	6.4% 6/94
Infections and infestations Otitis media	0.00% 0/104	0.00% 0/97	1.1% 1/94
Infections and infestations Parasitic gastroenteritis	0.96% 1/104	0.00% 0/97	0.00% 0/94
Infections and infestations Pharyngitis	1.9% 2/104	3.1% 3/97	2.1% 2/94
Infections and infestations Pharyngotonsillitis	0.96% 1/104	1.0% 1/97	0.00% 0/94
Infections and infestations Pneumonia	0.00% 0/104	0.00% 0/97	1.1% 1/94
Infections and infestations Rash pustular	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Respiratory tract infection	0.00% 0/104	0.00% 0/97	2.1% 2/94
Infections and infestations Respiratory tract infection viral	0.96% 1/104	0.00% 0/97	0.00% 0/94
Infections and infestations Rhinitis	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Sinusitis	0.00% 0/104	1.0% 1/97	1.1% 1/94
Infections and infestations Skin infection	0.00% 0/104	1.0% 1/97	0.00% 0/94
Infections and infestations Tonsillitis	0.96% 1/104	1.0% 1/97	2.1% 2/94
Infections and infestations Upper respiratory tract infection	9.6% 10/104	8.2% 8/97	9.6% 9/94
Infections and infestations Urinary tract infection	0.96% 1/104	1.0% 1/97	1.1% 1/94
Infections and infestations Varicella	0.00% 0/104	0.00% 0/97	1.1% 1/94
Infections and infestations Viral infection	1.9% 2/104	3.1% 3/97	0.00% 0/94
Infections and infestations Viral upper respiratory tract infection	0.00% 0/104	1.0% 1/97	1.1% 1/94
Injury, poisoning and procedural complications Animal bite	0.96% 1/104	1.0% 1/97	0.00% 0/94
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/104	0.00% 0/97	1.1% 1/94
Injury, poisoning and procedural complications Contusion	0.96% 1/104	2.1% 2/97	1.1% 1/94
Injury, poisoning and procedural complications Ear abrasion	0.96% 1/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Eye contusion	0.00% 0/104	2.1% 2/97	0.00% 0/94
Injury, poisoning and procedural complications Fall	0.96% 1/104	2.1% 2/97	2.1% 2/94
Injury, poisoning and procedural complications Head injury	0.96% 1/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Laceration	0.96% 1/104	0.00% 0/97	1.1% 1/94
Injury, poisoning and procedural complications Ligament sprain	1.9% 2/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Limb injury	0.00% 0/104	0.00% 0/97	1.1% 1/94
Injury, poisoning and procedural complications Lip injury	0.96% 1/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/104	1.0% 1/97	1.1% 1/94
Injury, poisoning and procedural complications Scar	0.96% 1/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Scratch	0.96% 1/104	0.00% 0/97	1.1% 1/94
Injury, poisoning and procedural complications Skin abrasion	0.96% 1/104	2.1% 2/97	3.2% 3/94
Injury, poisoning and procedural complications Soft tissue injury	0.96% 1/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Thermal burn	0.96% 1/104	0.00% 0/97	0.00% 0/94
Injury, poisoning and procedural complications Wound	0.96% 1/104	1.0% 1/97	0.00% 0/94
Investigations Body temperature increased	0.96% 1/104	0.00% 0/97	0.00% 0/94
Investigations Gamma-glutamyl transferase increased	0.96% 1/104	0.00% 0/97	1.1% 1/94
Investigations Heart rate decreased	0.96% 1/104	0.00% 0/97	0.00% 0/94
Investigations Hepatic enzyme increased	0.00% 0/104	1.0% 1/97	0.00% 0/94
Investigations Weight increased	3.8% 4/104	13.4% 13/97	4.3% 4/94
Investigations White blood cell count increased	0.00% 0/104	0.00% 0/97	0.00% 0/94
Metabolism and nutrition disorders Decreased appetite	0.00% 0/104	1.0% 1/97	1.1% 1/94
Metabolism and nutrition disorders Dehydration	0.00% 0/104	1.0% 1/97	0.00% 0/94
Metabolism and nutrition disorders Hyperphagia	0.96% 1/104	0.00% 0/97	0.00% 0/94
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/104	0.00% 0/97	1.1% 1/94
Metabolism and nutrition disorders Increased appetite	6.7% 7/104	10.3% 10/97	4.3% 4/94
Metabolism and nutrition disorders Overweight	0.96% 1/104	0.00% 0/97	0.00% 0/94
Musculoskeletal and connective tissue disorders Arthralgia	0.96% 1/104	0.00% 0/97	1.1% 1/94
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/104	0.00% 0/97	1.1% 1/94
Nervous system disorders Aphasia	0.96% 1/104	0.00% 0/97	0.00% 0/94
Nervous system disorders Balance disorder	0.96% 1/104	0.00% 0/97	0.00% 0/94
Nervous system disorders Clonus	0.00% 0/104	0.00% 0/97	1.1% 1/94
Nervous system disorders Disturbance in attention	0.96% 1/104	1.0% 1/97	0.00% 0/94
Nervous system disorders Dizziness	3.8% 4/104	3.1% 3/97	1.1% 1/94
Nervous system disorders Headache	3.8% 4/104	7.2% 7/97	6.4% 6/94
Nervous system disorders Hypersomnia	1.9% 2/104	1.0% 1/97	2.1% 2/94
Nervous system disorders Lethargy	1.9% 2/104	2.1% 2/97	0.00% 0/94
Nervous system disorders Migraine	0.96% 1/104	0.00% 0/97	0.00% 0/94
Nervous system disorders Nystagmus	0.96% 1/104	0.00% 0/97	0.00% 0/94
Nervous system disorders Partial seizures with secondary generalisation	0.96% 1/104	1.0% 1/97	1.1% 1/94
Nervous system disorders Poor quality sleep	0.00% 0/104	1.0% 1/97	0.00% 0/94
Nervous system disorders Psychomotor hyperactivity	0.96% 1/104	0.00% 0/97	1.1% 1/94
Nervous system disorders Seizure	5.8% 6/104	1.0% 1/97	4.3% 4/94
Nervous system disorders Somnolence	17.3% 18/104	25.8% 25/97	13.8% 13/94
Nervous system disorders Tunnel vision	0.96% 1/104	0.00% 0/97	0.00% 0/94
Psychiatric disorders Abnormal behaviour	0.00% 0/104	1.0% 1/97	0.00% 0/94
Psychiatric disorders Aggression	0.96% 1/104	0.00% 0/97	0.00% 0/94
Psychiatric disorders Agitation	0.96% 1/104	1.0% 1/97	0.00% 0/94
Psychiatric disorders Disinhibition	0.96% 1/104	0.00% 0/97	0.00% 0/94
Psychiatric disorders Initial insomnia	0.00% 0/104	1.0% 1/97	1.1% 1/94
Psychiatric disorders Insomnia	0.96% 1/104	1.0% 1/97	0.00% 0/94
Psychiatric disorders Irritability	0.96% 1/104	3.1% 3/97	1.1% 1/94
Psychiatric disorders Middle insomnia	0.00% 0/104	0.00% 0/97	1.1% 1/94
Psychiatric disorders Mood altered	0.96% 1/104	0.00% 0/97	0.00% 0/94
Psychiatric disorders Mood swings	0.00% 0/104	0.00% 0/97	1.1% 1/94
Psychiatric disorders Mutism	0.96% 1/104	0.00% 0/97	0.00% 0/94
Psychiatric disorders Nervousness	0.00% 0/104	1.0% 1/97	0.00% 0/94
Psychiatric disorders Sleep disorder	0.00% 0/104	0.00% 0/97	1.1% 1/94
Psychiatric disorders Tic	0.00% 0/104	1.0% 1/97	0.00% 0/94
Renal and urinary disorders Urinary retention	0.00% 0/104	0.00% 0/97	1.1% 1/94
Reproductive system and breast disorders Breast swelling	0.00% 0/104	0.00% 0/97	1.1% 1/94
Reproductive system and breast disorders Pruritus genital	0.96% 1/104	0.00% 0/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Asthma	0.96% 1/104	0.00% 0/97	1.1% 1/94
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/104	0.00% 0/97	1.1% 1/94
Respiratory, thoracic and mediastinal disorders Cough	8.7% 9/104	2.1% 2/97	3.2% 3/94
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/104	2.1% 2/97	2.1% 2/94
Respiratory, thoracic and mediastinal disorders Hypopnoea	0.96% 1/104	0.00% 0/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.96% 1/104	0.00% 0/97	1.1% 1/94
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/104	1.0% 1/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/104	1.0% 1/97	0.00% 0/94
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.9% 2/104	0.00% 0/97	1.1% 1/94
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/104	1.0% 1/97	0.00% 0/94
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/104	0.00% 0/97	0.00% 0/94
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/104	1.0% 1/97	0.00% 0/94
Vascular disorders Haematoma	0.00% 0/104	1.0% 1/97	0.00% 0/94
Vascular disorders Hypertension	0.00% 0/104	1.0% 1/97	0.00% 0/94
Vascular disorders Hypotension	0.96% 1/104	0.00% 0/97	0.00% 0/94

Additional Information

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Results disclosure agreements

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