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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

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ClinicalTrials.gov Identifier: NCT01463306
Recruitment Status : Completed
First Posted : November 1, 2011
Results First Posted : February 21, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy, Partial Seizures
Epilepsy, Primary Generalized Tonic-Clonic Seizures
Intervention Drug: Pregabalin
Enrollment 605
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 384 210 11
Completed 298 158 6
Not Completed 86 52 5
Reason Not Completed
Adverse Event             6             9             3
Death             3             3             0
Lack of Efficacy             22             16             1
Lost to Follow-up             5             2             0
Protocol Violation             4             0             0
Withdrawal by Subject             19             9             1
Other             26             13             0
Approval expiry at site             1             0             0
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 384 210 11 605
Hide Baseline Analysis Population Description
Safety population included participants who took at least 1 dose of the study medication in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 384 participants 210 participants 11 participants 605 participants
12.56  (11.43) 13.03  (12.39) 11.80  (3.87) 12.71  (11.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 384 participants 210 participants 11 participants 605 participants
Female
176
  45.8%
103
  49.0%
7
  63.6%
286
  47.3%
Male
208
  54.2%
107
  51.0%
4
  36.4%
319
  52.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 384 participants 210 participants 11 participants 605 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
85
  22.1%
47
  22.4%
1
   9.1%
133
  22.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   0.8%
1
   0.5%
0
   0.0%
4
   0.7%
White
294
  76.6%
160
  76.2%
9
  81.8%
463
  76.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   0.5%
2
   1.0%
1
   9.1%
5
   0.8%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent 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.
Time Frame Baseline (Day 1) up to 13 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who took at least 1 dose of the study medication in the study.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 384 210 11
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With AEs
252
  65.6%
140
  66.7%
10
  90.9%
Participants With SAEs
53
  13.8%
23
  11.0%
1
   9.1%
Participants With Treatment Related AEs
104
  27.1%
65
  31.0%
9
  81.8%
Participants With Treatment Related SAEs
0
   0.0%
1
   0.5%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
Hide Description 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.
Time Frame Baseline up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 384 210 11
Measure Type: Count of Participants
Unit of Measure: Participants
Physical Examination Number Analyzed 369 participants 199 participants 9 participants
8
   2.2%
6
   3.0%
0
   0.0%
Neurological Examination Number Analyzed 368 participants 199 participants 9 participants
10
   2.7%
4
   2.0%
2
  22.2%
3.Primary Outcome
Title Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
Hide Description 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.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who took at least 1 dose of the study medication in the study.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 384 210 11
Measure Type: Count of Participants
Unit of Measure: Participants
Max. increase from baseline in SBP>=30 mmHg
9
   2.3%
1
   0.5%
0
   0.0%
Max. decrease from baseline in SBP>=30 mmHg
8
   2.1%
5
   2.4%
0
   0.0%
Max. increase from baseline in DBP>=20 mmHg
34
   8.9%
16
   7.6%
1
   9.1%
Max. decrease from baseline in DBP>=20 mmHg
22
   5.7%
6
   2.9%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Baseline
Hide Description 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).
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 213 98 9
Measure Type: Count of Participants
Unit of Measure: Participants
Pubic Hair Number Analyzed 212 participants 98 participants 9 participants
Stage 1
95
  44.8%
44
  44.9%
4
  44.4%
Stage 2
34
  16.0%
17
  17.3%
1
  11.1%
Stage 3
33
  15.6%
16
  16.3%
0
   0.0%
Stage 4
34
  16.0%
15
  15.3%
0
   0.0%
Stage 5
16
   7.5%
6
   6.1%
2
  22.2%
Not Done
0
   0.0%
0
   0.0%
2
  22.2%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
Breast Number Analyzed 122 participants 52 participants 6 participants
Stage 1
37
  30.3%
18
  34.6%
2
  33.3%
Stage 2
17
  13.9%
8
  15.4%
1
  16.7%
Stage 3
15
  12.3%
7
  13.5%
0
   0.0%
Stage 4
19
  15.6%
7
  13.5%
0
   0.0%
Stage 5
9
   7.4%
3
   5.8%
2
  33.3%
Not Done
1
   0.8%
0
   0.0%
1
  16.7%
Missing
24
  19.7%
9
  17.3%
0
   0.0%
Genitalia Number Analyzed 133 participants 64 participants 3 participants
Stage 1
50
  37.6%
23
  35.9%
2
  66.7%
Stage 2
24
  18.0%
11
  17.2%
0
   0.0%
Stage 3
20
  15.0%
10
  15.6%
0
   0.0%
Stage 4
13
   9.8%
7
  10.9%
0
   0.0%
Stage 5
7
   5.3%
3
   4.7%
0
   0.0%
Not Done
0
   0.0%
1
   1.6%
1
  33.3%
Missing
19
  14.3%
9
  14.1%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 12
Hide Description 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).
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 186 89 5
Measure Type: Count of Participants
Unit of Measure: Participants
Pubic Hair Number Analyzed 186 participants 89 participants 5 participants
Stage 1
68
  36.6%
38
  42.7%
2
  40.0%
Stage 2
35
  18.8%
17
  19.1%
1
  20.0%
Stage 3
38
  20.4%
12
  13.5%
0
   0.0%
Stage 4
21
  11.3%
11
  12.4%
0
   0.0%
Stage 5
23
  12.4%
10
  11.2%
1
  20.0%
Not Done
1
   0.5%
1
   1.1%
1
  20.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
Breast Number Analyzed 82 participants 37 participants 4 participants
Stage 1
27
  32.9%
15
  40.5%
2
  50.0%
Stage 2
17
  20.7%
8
  21.6%
1
  25.0%
Stage 3
19
  23.2%
5
  13.5%
0
   0.0%
Stage 4
7
   8.5%
3
   8.1%
0
   0.0%
Stage 5
12
  14.6%
5
  13.5%
1
  25.0%
Not Done
0
   0.0%
1
   2.7%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
Genitalia Number Analyzed 104 participants 52 participants 1 participants
Stage 1
40
  38.5%
19
  36.5%
1
 100.0%
Stage 2
22
  21.2%
12
  23.1%
0
   0.0%
Stage 3
20
  19.2%
10
  19.2%
0
   0.0%
Stage 4
9
   8.7%
5
   9.6%
0
   0.0%
Stage 5
13
  12.5%
6
  11.5%
0
   0.0%
Not Done
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
Hide Description In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported.
Time Frame Baseline up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 377 203 9
Measure Type: Count of Participants
Unit of Measure: Participants
Weight increase from baseline >=7%
290
  76.9%
147
  72.4%
8
  88.9%
Weight decrease from baseline >=7%
2
   0.5%
4
   2.0%
0
   0.0%
7.Primary Outcome
Title Absolute Values for Body Height at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 384 210 11
Mean (Standard Deviation)
Unit of Measure: Centimeters
Age: 1 Month to <2 Years Number Analyzed 37 participants 23 participants 0 participants
74.7  (7.91) 74.8  (8.24)
Age: 2 Years to <4 Years Number Analyzed 60 participants 42 participants 0 participants
92.2  (7.13) 91.0  (8.21)
Age: 4 Years to <10 Years Number Analyzed 92 participants 43 participants 4 participants
119.3  (15.16) 118.5  (11.36) 126.0  (12.60)
Age: 10 Years to 16 Years Number Analyzed 126 participants 57 participants 7 participants
153.5  (14.50) 154.7  (11.88) 153.4  (7.06)
Age: >=17 Years Number Analyzed 69 participants 45 participants 0 participants
170.4  (9.18) 170.7  (9.99)
8.Primary Outcome
Title Absolute Values for Body Height at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 377 202 9
Mean (Standard Deviation)
Unit of Measure: Centimeters
Age: 1 Month to <2 Years Number Analyzed 36 participants 22 participants 0 participants
84.4  (7.27) 85.3  (9.01)
Age: 2 Years to <4 Years Number Analyzed 58 participants 39 participants 0 participants
99.3  (7.90) 98.1  (8.94)
Age: 4 Years to <10 Years Number Analyzed 91 participants 43 participants 3 participants
128.2  (15.94) 126.6  (10.80) 128.2  (13.08)
Age: 10 Years to 16 Years Number Analyzed 125 participants 55 participants 6 participants
158.1  (13.64) 160.5  (11.87) 153.7  (6.58)
Age: >=17 Years Number Analyzed 67 participants 43 participants 0 participants
170.8  (9.54) 170.6  (10.14)
9.Primary Outcome
Title Number of Participants With Incidence of Laboratory Abnormalities
Hide Description 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.
Time Frame Baseline up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for laboratory abnormalities.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 374 204 9
Measure Type: Count of Participants
Unit of Measure: Participants
297
  79.4%
164
  80.4%
8
  88.9%
10.Primary Outcome
Title Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters
Hide Description 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.
Time Frame Baseline up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 357 194 9
Measure Type: Count of Participants
Unit of Measure: Participants
Max PR interval IFB PctChg >=25/50%
1
   0.3%
0
   0.0%
0
   0.0%
Max QRS complex IFB PctChg >=50%
0
   0.0%
0
   0.0%
0
   0.0%
Max QTcB interval IFB change >=30 - <60
29
   8.1%
11
   5.7%
0
   0.0%
Max QTcB interval IFB change >=60
0
   0.0%
0
   0.0%
0
   0.0%
Max QTcF interval IFB change >=30 - <60
18
   5.0%
9
   4.6%
1
  11.1%
Max QTcF interval IFB change >=60
1
   0.3%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title 28-Days Seizure Rate at Week 1
Hide Description 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.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 380 209 11
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 270 participants 147 participants 11 participants
102.89  (235.73) 190.45  (1143.83) 17.83  (32.18)
Primary Generalized Tonic Clonic Seizures Number Analyzed 110 participants 62 participants 0 participants
2.07  (2.98) 2.39  (4.53)
12.Primary Outcome
Title 28-Days Seizure Rate at Month 1
Hide Description 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.
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 378 203 10
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 269 participants 142 participants 10 participants
96.39  (258.09) 178.53  (1114.79) 33.42  (54.21)
Primary Generalized Tonic Clonic Seizures Number Analyzed 109 participants 61 participants 0 participants
1.43  (2.16) 1.66  (2.86)
13.Primary Outcome
Title 28-Days Seizure Rate at Month 2
Hide Description 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.
Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 373 193 8
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 263 participants 135 participants 8 participants
79.33  (196.31) 89.09  (579.42) 22.16  (46.70)
Primary Generalized Tonic Clonic Seizures Number Analyzed 110 participants 58 participants 0 participants
1.27  (1.80) 1.36  (2.63)
14.Primary Outcome
Title 28-Days Seizure Rate at Month 4
Hide Description 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.
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 352 185 6
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 247 participants 131 participants 6 participants
67.32  (190.44) 58.33  (320.32) 15.45  (25.23)
Primary Generalized Tonic Clonic Seizures Number Analyzed 105 participants 54 participants 0 participants
1.09  (1.88) 0.72  (0.91)
15.Primary Outcome
Title 28-Days Seizure Rate at Month 6
Hide Description 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.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
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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.
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.
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 Number of Participants Analyzed 330 175 6
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 237 participants 124 participants 6 participants
50.18  (125.26) 51.10  (212.59) 4.25  (6.06)
Primary Generalized Tonic Clonic Seizures Number Analyzed 93 participants 51 participants 0 participants
1.02  (1.61) 0.79  (1.21)
16.Primary Outcome
Title 28-Days Seizure Rate at Month 9
Hide Description 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.
Time Frame Month 9
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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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 310 164 6
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 225 participants 121 participants 6 participants
38.17  (87.75) 43.13  (141.96) 3.00  (3.93)
Primary Generalized Tonic Clonic Seizures Number Analyzed 85 participants 43 participants 0 participants
0.96  (1.69) 0.62  (0.99)
17.Primary Outcome
Title 28-Days Seizure Rate at Month 12/Early Termination
Hide Description 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.
Time Frame Month 12/Early Termination
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Hide Analysis Population Description
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 and "Number Analyzed" signifies number of participants evaluable for specified rows.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 374 206 8
Mean (Standard Deviation)
Unit of Measure: Seizures Per 28-Days
Partial Onset Seizures Number Analyzed 266 participants 146 participants 8 participants
56.04  (147.20) 117.88  (896.40) 11.08  (16.55)
Primary Generalized Tonic Clonic Seizures Number Analyzed 108 participants 60 participants 0 participants
1.02  (1.71) 1.33  (3.20)
18.Secondary Outcome
Title 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)
Hide Description 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".
Time Frame Baseline (Day 1), Post-baseline on Day 1 up to 12 Months
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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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 258 134 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 254 participants 132 participants 10 participants
3
   1.2%
2
   1.5%
1
  10.0%
Post-baseline on Day 1 up to 12 Months Number Analyzed 257 participants 134 participants 10 participants
3
   1.2%
2
   1.5%
0
   0.0%
19.Secondary Outcome
Title 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)
Hide Description 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").
Time Frame Baseline (Day 1), Post-baseline up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 258 134 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 254 participants 132 participants 10 participants
1
   0.4%
1
   0.8%
0
   0.0%
Post-baseline on Day 1 up to 12 Months Number Analyzed 257 participants 134 participants 10 participants
2
   0.8%
0
   0.0%
0
   0.0%
20.Secondary Outcome
Title Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task
Hide Description 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.
Time Frame Month 12
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Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 97 51 7
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement (RCI <= -1.65)
21
  21.6%
8
  15.7%
2
  28.6%
Decline (RCI =>1.65)
13
  13.4%
6
  11.8%
1
  14.3%
21.Secondary Outcome
Title Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task
Hide Description 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.
Time Frame Month 12
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Hide Analysis Population Description
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.
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 96 50 7
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement (RCI <=-1.65)
17
  17.7%
9
  18.0%
2
  28.6%
Decline (RCI =>1.65)
16
  16.7%
6
  12.0%
2
  28.6%
Time Frame Baseline up to 13 Months
Adverse Event Reporting Description Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population was evaluated.
 
Arm/Group Title Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/384 (0.78%)   4/210 (1.90%)   0/11 (0.00%) 
Hide Serious Adverse Events
Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/384 (13.80%)   23/210 (10.95%)   1/11 (9.09%) 
Blood and lymphatic system disorders       
Deficiency anaemia * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Cardiac disorders       
Cardio-respiratory arrest * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Cardiopulmonary failure * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Cyanosis * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Gastrointestinal disorders       
Colitis * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Constipation * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Gastrooesophageal reflux disease * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Gingival hypertrophy * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Saliva discolouration * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
General disorders       
Pyrexia * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Infections and infestations       
Appendicitis * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Bronchitis * 1  3/384 (0.78%)  1/210 (0.48%)  0/11 (0.00%) 
Cellulitis * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Dengue fever * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Ear infection * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Gastroenteritis * 1  0/384 (0.00%)  3/210 (1.43%)  0/11 (0.00%) 
Giardiasis * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Peritonitis * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Pharyngotonsillitis * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Pneumonia * 1  17/384 (4.43%)  6/210 (2.86%)  0/11 (0.00%) 
Respiratory tract chlamydial infection * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Respiratory tract infection * 1  1/384 (0.26%)  1/210 (0.48%)  0/11 (0.00%) 
Systemic viral infection * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Upper respiratory tract infection * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Urinary tract infection * 1  2/384 (0.52%)  0/210 (0.00%)  0/11 (0.00%) 
Viral infection * 1  2/384 (0.52%)  0/210 (0.00%)  0/11 (0.00%) 
Injury, poisoning and procedural complications       
Brain herniation * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Concussion * 1  2/384 (0.52%)  0/210 (0.00%)  0/11 (0.00%) 
Epiphyseal injury * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Humerus fracture * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Unintentional medical device removal * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  2/384 (0.52%)  1/210 (0.48%)  0/11 (0.00%) 
Electrolyte imbalance * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Hyponatraemia * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Periostitis * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Nervous system disorders       
Brain oedema * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Cerebral haemorrhage * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Epilepsy * 1  1/384 (0.26%)  2/210 (0.95%)  0/11 (0.00%) 
Partial seizures * 1  3/384 (0.78%)  0/210 (0.00%)  0/11 (0.00%) 
Postictal state * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Seizure * 1  8/384 (2.08%)  6/210 (2.86%)  0/11 (0.00%) 
Somnolence * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Status epilepticus * 1  2/384 (0.52%)  0/210 (0.00%)  0/11 (0.00%) 
Product Issues       
Device dislocation * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Device occlusion * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Psychiatric disorders       
Anxiety * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Emotional disorder * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Suicide attempt * 1  2/384 (0.52%)  0/210 (0.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Asthma * 1  1/384 (0.26%)  1/210 (0.48%)  0/11 (0.00%) 
Bronchial obstruction * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Dyspnoea * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Pneumonia aspiration * 1  2/384 (0.52%)  0/210 (0.00%)  0/11 (0.00%) 
Respiratory arrest * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
Respiratory failure * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders       
Henoch-Schonlein purpura * 1  0/384 (0.00%)  1/210 (0.48%)  0/11 (0.00%) 
Social circumstances       
Physical abuse * 1  1/384 (0.26%)  0/210 (0.00%)  0/11 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin: Previous and Current Placebo-Previous to Pregabalin-Current Direct Pregabalin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   186/384 (48.44%)   103/210 (49.05%)   10/11 (90.91%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  4/384 (1.04%)  1/210 (0.48%)  2/11 (18.18%) 
Constipation * 1  10/384 (2.60%)  4/210 (1.90%)  1/11 (9.09%) 
Diarrhoea * 1  20/384 (5.21%)  9/210 (4.29%)  1/11 (9.09%) 
Vomiting * 1  15/384 (3.91%)  11/210 (5.24%)  2/11 (18.18%) 
General disorders       
Fatigue * 1  8/384 (2.08%)  2/210 (0.95%)  1/11 (9.09%) 
Pyrexia * 1  54/384 (14.06%)  22/210 (10.48%)  1/11 (9.09%) 
Infections and infestations       
Lyme disease * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Nasopharyngitis * 1  26/384 (6.77%)  12/210 (5.71%)  0/11 (0.00%) 
Pneumonia * 1  13/384 (3.39%)  12/210 (5.71%)  0/11 (0.00%) 
Sinusitis * 1  2/384 (0.52%)  2/210 (0.95%)  1/11 (9.09%) 
Upper respiratory tract infection * 1  60/384 (15.63%)  30/210 (14.29%)  0/11 (0.00%) 
Viral infection * 1  15/384 (3.91%)  11/210 (5.24%)  0/11 (0.00%) 
Injury, poisoning and procedural complications       
Arthropod bite * 1  6/384 (1.56%)  0/210 (0.00%)  1/11 (9.09%) 
Concussion * 1  1/384 (0.26%)  1/210 (0.48%)  1/11 (9.09%) 
Foot fracture * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Investigations       
Blood triglycerides increased * 1  1/384 (0.26%)  3/210 (1.43%)  1/11 (9.09%) 
Platelet count abnormal * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Red blood cell count abnormal * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Weight increased * 1  28/384 (7.29%)  12/210 (5.71%)  2/11 (18.18%) 
White blood cell count abnormal * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Metabolism and nutrition disorders       
Increased appetite * 1  10/384 (2.60%)  9/210 (4.29%)  2/11 (18.18%) 
Musculoskeletal and connective tissue disorders       
Arthropathy * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Nervous system disorders       
Disturbance in attention * 1  3/384 (0.78%)  2/210 (0.95%)  1/11 (9.09%) 
Dizziness * 1  19/384 (4.95%)  10/210 (4.76%)  1/11 (9.09%) 
Dysdiadochokinesis * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Headache * 1  24/384 (6.25%)  8/210 (3.81%)  4/11 (36.36%) 
Lethargy * 1  1/384 (0.26%)  1/210 (0.48%)  1/11 (9.09%) 
Psychomotor hyperactivity * 1  4/384 (1.04%)  2/210 (0.95%)  1/11 (9.09%) 
Resting tremor * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Seizure * 1  22/384 (5.73%)  12/210 (5.71%)  1/11 (9.09%) 
Somnolence * 1  26/384 (6.77%)  27/210 (12.86%)  1/11 (9.09%) 
Psychiatric disorders       
Abnormal behaviour * 1  1/384 (0.26%)  0/210 (0.00%)  1/11 (9.09%) 
Aggression * 1  5/384 (1.30%)  2/210 (0.95%)  1/11 (9.09%) 
Behaviour disorder * 1  2/384 (0.52%)  2/210 (0.95%)  1/11 (9.09%) 
Mood altered * 1  1/384 (0.26%)  0/210 (0.00%)  1/11 (9.09%) 
Mood swings * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
Staring * 1  1/384 (0.26%)  0/210 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  23/384 (5.99%)  14/210 (6.67%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash * 1  9/384 (2.34%)  3/210 (1.43%)  1/11 (9.09%) 
Rash macular * 1  0/384 (0.00%)  0/210 (0.00%)  1/11 (9.09%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
1 death occurred in reporting arm "Placebo-Previous to Pregabalin-Current" after participant completed the study and is captured in All-cause mortality section.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
ClinicalTrials.gov Identifier: NCT01463306    
Other Study ID Numbers: A0081106
2011-001412-65 ( EudraCT Number )
First Submitted: October 17, 2011
First Posted: November 1, 2011
Results First Submitted: January 31, 2020
Results First Posted: February 21, 2020
Last Update Posted: January 20, 2021