Trial Outcomes & Findings for A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures (NCT NCT01463306)

Last Updated: 2021-01-20

Results Overview

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 are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

605 participants

Primary outcome timeframe

Baseline (Day 1) up to 13 Months

Results posted on

2021-01-20

Participant Flow

Reporting arms are on basis of pediatric and adult participants who consented to continue from previous studies receiving either pregabalin or placebo and pediatric participants who directly enrolled in this study. Previous studies- A0081041 (NCT01389596), A0081042 (NCT02072824), A0081105 (NCT01747915).

Participant milestones

Participant milestones
Measure	Pregabalin: Previous and Current Pediatric and adult participants with partial onset seizures (POS) and primary generalized tonic-clonic (PGTC) seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (\<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (\>=) 4 years. Pediatric participants with body weight \>=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Overall Study STARTED	384	210	11
Overall Study COMPLETED	298	158	6
Overall Study NOT COMPLETED	86	52	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin: Previous and Current Pediatric and adult participants with partial onset seizures (POS) and primary generalized tonic-clonic (PGTC) seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (\<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (\>=) 4 years. Pediatric participants with body weight \>=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Overall Study Adverse Event	6	9	3
Overall Study Death	3	3	0
Overall Study Lack of Efficacy	22	16	1
Overall Study Lost to Follow-up	5	2	0
Overall Study Protocol Violation	4	0	0
Overall Study Withdrawal by Subject	19	9	1
Overall Study Other	26	13	0
Overall Study Approval expiry at site	1	0	0

Baseline Characteristics

A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin: Previous and Current n=384 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=210 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=11 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.	Total n=605 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Age, Continuous	12.56 years STANDARD_DEVIATION 11.43 • n=5 Participants	13.03 years STANDARD_DEVIATION 12.39 • n=7 Participants	11.80 years STANDARD_DEVIATION 3.87 • n=5 Participants	12.71 years STANDARD_DEVIATION 11.67 • n=4 Participants
Sex: Female, Male Female	176 Participants n=5 Participants	103 Participants n=7 Participants	7 Participants n=5 Participants	286 Participants n=4 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	107 Participants n=7 Participants	4 Participants n=5 Participants	319 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	85 Participants n=5 Participants	47 Participants n=7 Participants	1 Participants n=5 Participants	133 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	294 Participants n=5 Participants	160 Participants n=7 Participants	9 Participants n=5 Participants	463 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to 13 Months

Population: Safety population included participants who took at least 1 dose of the study medication in the study.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=384 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=210 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=11 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs Participants With AEs	252 Participants	140 Participants	10 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs Participants With Treatment Related SAEs	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs Participants With SAEs	53 Participants	23 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs Participants With Treatment Related AEs	104 Participants	65 Participants	9 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 Months

Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=384 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=210 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=11 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months Physical Examination	8 Participants	6 Participants	0 Participants
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months Neurological Examination	10 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 months

Population: Safety population included participants who took at least 1 dose of the study medication in the study.

Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) \>=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) \>=20 mmHg.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=384 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=210 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=11 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities Max. increase from baseline in SBP>=30 mmHg	9 Participants	1 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities Max. decrease from baseline in SBP>=30 mmHg	8 Participants	5 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities Max. increase from baseline in DBP>=20 mmHg	34 Participants	16 Participants	1 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities Max. decrease from baseline in DBP>=20 mmHg	22 Participants	6 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=213 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=98 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=9 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Stage 4	34 Participants	15 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Missing	0 Participants	0 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Stage 3	15 Participants	7 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Stage 1	95 Participants	44 Participants	4 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Stage 2	34 Participants	17 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Stage 3	33 Participants	16 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Stage 5	16 Participants	6 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Pubic Hair · Not Done	0 Participants	0 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Stage 1	37 Participants	18 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Stage 2	17 Participants	8 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Stage 4	19 Participants	7 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Stage 5	9 Participants	3 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Not Done	1 Participants	0 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Breast · Missing	24 Participants	9 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Stage 1	50 Participants	23 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Stage 2	24 Participants	11 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Stage 3	20 Participants	10 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Stage 4	13 Participants	7 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Stage 5	7 Participants	3 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Not Done	0 Participants	1 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Baseline Genitalia · Missing	19 Participants	9 Participants	0 Participants

PRIMARY outcome

Timeframe: Month 12

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=186 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=89 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=5 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Stage 1	68 Participants	38 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Stage 2	35 Participants	17 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Stage 3	38 Participants	12 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Stage 4	21 Participants	11 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Stage 5	23 Participants	10 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Not Done	1 Participants	1 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Pubic Hair · Missing	0 Participants	0 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Stage 1	27 Participants	15 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Stage 2	17 Participants	8 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Stage 3	19 Participants	5 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Stage 4	7 Participants	3 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Stage 5	12 Participants	5 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Not Done	0 Participants	1 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Breast · Missing	0 Participants	0 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Stage 1	40 Participants	19 Participants	1 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Stage 2	22 Participants	12 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Stage 3	20 Participants	10 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Stage 4	9 Participants	5 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Stage 5	13 Participants	6 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Not Done	0 Participants	0 Participants	0 Participants
Number of Participants With Tanner Staging Evaluation at Month 12 Genitalia · Missing	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 Months

Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

In this outcome measure number of participants with increase and decrease of \>=7% in body weight, from baseline up to 12 months are reported.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=377 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=203 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=9 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months Weight increase from baseline >=7%	290 Participants	147 Participants	8 Participants
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months Weight decrease from baseline >=7%	2 Participants	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here,"Number Analyzed" signifies number of participants evaluable for specified rows.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=384 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=210 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=11 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Absolute Values for Body Height at Baseline Age: 1 Month to <2 Years	74.7 Centimeters Standard Deviation 7.91	74.8 Centimeters Standard Deviation 8.24	—
Absolute Values for Body Height at Baseline Age: 2 Years to <4 Years	92.2 Centimeters Standard Deviation 7.13	91.0 Centimeters Standard Deviation 8.21	—
Absolute Values for Body Height at Baseline Age: 4 Years to <10 Years	119.3 Centimeters Standard Deviation 15.16	118.5 Centimeters Standard Deviation 11.36	126.0 Centimeters Standard Deviation 12.60
Absolute Values for Body Height at Baseline Age: 10 Years to 16 Years	153.5 Centimeters Standard Deviation 14.50	154.7 Centimeters Standard Deviation 11.88	153.4 Centimeters Standard Deviation 7.06
Absolute Values for Body Height at Baseline Age: >=17 Years	170.4 Centimeters Standard Deviation 9.18	170.7 Centimeters Standard Deviation 9.99	—

PRIMARY outcome

Timeframe: Month 12

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=377 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=202 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=9 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Absolute Values for Body Height at Month 12 Age: 1 Month to <2 Years	84.4 Centimeters Standard Deviation 7.27	85.3 Centimeters Standard Deviation 9.01	—
Absolute Values for Body Height at Month 12 Age: 2 Years to <4 Years	99.3 Centimeters Standard Deviation 7.90	98.1 Centimeters Standard Deviation 8.94	—
Absolute Values for Body Height at Month 12 Age: 4 Years to <10 Years	128.2 Centimeters Standard Deviation 15.94	126.6 Centimeters Standard Deviation 10.80	128.2 Centimeters Standard Deviation 13.08
Absolute Values for Body Height at Month 12 Age: 10 Years to 16 Years	158.1 Centimeters Standard Deviation 13.64	160.5 Centimeters Standard Deviation 11.87	153.7 Centimeters Standard Deviation 6.58
Absolute Values for Body Height at Month 12 Age: >=17 Years	170.8 Centimeters Standard Deviation 9.54	170.6 Centimeters Standard Deviation 10.14	—

PRIMARY outcome

Timeframe: Baseline up to 12 Months

Population: Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for laboratory abnormalities.

Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: \<0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil- absolute/%:\<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte- absolute/%:\>1.2\*ULN; total/direct/indirect bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; thyroxine, thyroid stimulating hormone \<0.8\*LLN/\>1.2\*ULN; cholesterol, triglycerides:\> \>1.3\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium: \<0.9\*LLN or \>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN, creatine kinase\>2.0\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketones, protein: \>=1, WBC, RBC:\>=20, bacteria \>20, hyaline casts/casts \>1); prothrombin (PT), PT international ratio\>1.1\*ULN.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=374 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=204 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=9 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Incidence of Laboratory Abnormalities	297 Participants	164 Participants	8 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 Months

Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond \[msec\]) percent change (PctChg) \>=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg\>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60. 'PctChg\>=25/50%': \>= 25% increase from baseline when baseline ECG parameter is \> 200 msec, and is \>= 50% increase from baseline when baseline ECG parameter is non-missing and \<=200 msec.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=357 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=194 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=9 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Max PR interval IFB PctChg >=25/50%	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Max QRS complex IFB PctChg >=50%	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Max QTcB interval IFB change >=30 - <60	29 Participants	11 Participants	0 Participants
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Max QTcB interval IFB change >=60	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Max QTcF interval IFB change >=30 - <60	18 Participants	9 Participants	1 Participants
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Max QTcF interval IFB change >=60	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 1

28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=380 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=209 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=11 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Week 1 Partial Onset Seizures	102.89 Seizures Per 28-Days Standard Deviation 235.73	190.45 Seizures Per 28-Days Standard Deviation 1143.83	17.83 Seizures Per 28-Days Standard Deviation 32.18
28-Days Seizure Rate at Week 1 Primary Generalized Tonic Clonic Seizures	2.07 Seizures Per 28-Days Standard Deviation 2.98	2.39 Seizures Per 28-Days Standard Deviation 4.53	—

PRIMARY outcome

Timeframe: Month 1

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=378 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=203 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=10 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Month 1 Partial Onset Seizures	96.39 Seizures Per 28-Days Standard Deviation 258.09	178.53 Seizures Per 28-Days Standard Deviation 1114.79	33.42 Seizures Per 28-Days Standard Deviation 54.21
28-Days Seizure Rate at Month 1 Primary Generalized Tonic Clonic Seizures	1.43 Seizures Per 28-Days Standard Deviation 2.16	1.66 Seizures Per 28-Days Standard Deviation 2.86	—

PRIMARY outcome

Timeframe: Month 2

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=373 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=193 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=8 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Month 2 Partial Onset Seizures	79.33 Seizures Per 28-Days Standard Deviation 196.31	89.09 Seizures Per 28-Days Standard Deviation 579.42	22.16 Seizures Per 28-Days Standard Deviation 46.70
28-Days Seizure Rate at Month 2 Primary Generalized Tonic Clonic Seizures	1.27 Seizures Per 28-Days Standard Deviation 1.80	1.36 Seizures Per 28-Days Standard Deviation 2.63	—

PRIMARY outcome

Timeframe: Month 4

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=352 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=185 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=6 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Month 4 Partial Onset Seizures	67.32 Seizures Per 28-Days Standard Deviation 190.44	58.33 Seizures Per 28-Days Standard Deviation 320.32	15.45 Seizures Per 28-Days Standard Deviation 25.23
28-Days Seizure Rate at Month 4 Primary Generalized Tonic Clonic Seizures	1.09 Seizures Per 28-Days Standard Deviation 1.88	0.72 Seizures Per 28-Days Standard Deviation 0.91	—

PRIMARY outcome

Timeframe: Month 6

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=330 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=175 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=6 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Month 6 Partial Onset Seizures	50.18 Seizures Per 28-Days Standard Deviation 125.26	51.10 Seizures Per 28-Days Standard Deviation 212.59	4.25 Seizures Per 28-Days Standard Deviation 6.06
28-Days Seizure Rate at Month 6 Primary Generalized Tonic Clonic Seizures	1.02 Seizures Per 28-Days Standard Deviation 1.61	0.79 Seizures Per 28-Days Standard Deviation 1.21	—

PRIMARY outcome

Timeframe: Month 9

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=310 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=164 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=6 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Month 9 Partial Onset Seizures	38.17 Seizures Per 28-Days Standard Deviation 87.75	43.13 Seizures Per 28-Days Standard Deviation 141.96	3.00 Seizures Per 28-Days Standard Deviation 3.93
28-Days Seizure Rate at Month 9 Primary Generalized Tonic Clonic Seizures	0.96 Seizures Per 28-Days Standard Deviation 1.69	0.62 Seizures Per 28-Days Standard Deviation 0.99	—

PRIMARY outcome

Timeframe: Month 12/Early Termination

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=374 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=206 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=8 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
28-Days Seizure Rate at Month 12/Early Termination Primary Generalized Tonic Clonic Seizures	1.02 Seizures Per 28-Days Standard Deviation 1.71	1.33 Seizures Per 28-Days Standard Deviation 3.20	—
28-Days Seizure Rate at Month 12/Early Termination Partial Onset Seizures	56.04 Seizures Per 28-Days Standard Deviation 147.20	117.88 Seizures Per 28-Days Standard Deviation 896.40	11.08 Seizures Per 28-Days Standard Deviation 16.55

SECONDARY outcome

Timeframe: Baseline (Day 1), Post-baseline on Day 1 up to 12 Months

Population: Analysis population included participants who took at least 1 dose of the study medication in the study and with age \>=6 years. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods (not plan) without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan".

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=258 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=134 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=10 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) Baseline	3 Participants	2 Participants	1 Participants
Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) Post-baseline on Day 1 up to 12 Months	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Post-baseline up to 12 Months

Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior").

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=258 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=134 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=10 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) Baseline	1 Participants	1 Participants	0 Participants
Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) Post-baseline on Day 1 up to 12 Months	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 12

Population: Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a "YES" response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI \<=-1.65, decline in cognition when RCI =\>1.65.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=97 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=51 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=7 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task Improvement (RCI <= -1.65)	21 Participants	8 Participants	2 Participants
Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task Decline (RCI =>1.65)	13 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 12

CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered "YES" if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI \<=-1.65, decline in cognition: RCI =\>1.65.

Outcome measures

Outcome measures
Measure	Pregabalin: Previous and Current n=96 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Placebo-Previous to Pregabalin-Current n=50 Participants Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months.	Direct Pregabalin n=7 Participants Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months.
Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task Improvement (RCI <=-1.65)	17 Participants	9 Participants	2 Participants
Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task Decline (RCI =>1.65)	16 Participants	6 Participants	2 Participants

Adverse Events

Pregabalin: Previous and Current

Serious events: 53 serious events

Other events: 186 other events

Deaths: 3 deaths

Placebo-Previous to Pregabalin-Current

Serious events: 23 serious events

Other events: 103 other events

Deaths: 4 deaths

Direct Pregabalin

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER