Epilepsies, Partial
Conditions
Keywords
Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
Brief summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.
Interventions
DRUGPlacebo
Placebo
DRUGPregabalin
Orally-administered pregabalin
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* Partial onset seizures, incompletely controlled on 1-3 medications * At least 1 seizure per 28 days, on average
Exclusion criteria
* Primary generalized seizures * Progressive CNS pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Baseline to Day 7 | Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE. |
| Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Day 8 up to 28 days after open-label dose of study medication | Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8 | Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose. |
| Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose. |
| Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). |
| Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). |
| Number of Participants With Clinically Significant Change in Physical and Neurological Findings | Baseline up to 7 days post-last dose of study medication | Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator. |
| Plasma Decay Half-Life (t1/2): Single-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). |
| Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). |
| Apparent Oral Clearance (CL/F): Single-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). |
| Renal Clearance (CLr): Multiple-Dose Analysis | 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8 | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). |
| Renal Clearance (CLr): Single-Dose Analysis | 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8 | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants). |
| Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). |
| 28-Day Seizure Frequency Rate | Baseline up to 7 days post-last dose of study medication | Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)\*28. |
Countries
Mexico, South Korea, United States
Participant flow
Pre-assignment details
Participants who completed this study and who tolerated study medication were eligible to enroll in study A0081075 (NCT00448916), a 12-month open-label extension study of pregabalin.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Placebo (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 4 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 4 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Placebo (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 5 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 2 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Placebo (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 5 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 4 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 2 |
| Placebo (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 3 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Placebo (Age Cohort: 1 to 23 Months) | Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Placebo (Age Cohort: 2 to 6 Years) | Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Placebo (Age Cohort: 7 to 11 Years) | Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Placebo (Age Cohort: 12 to 16 Years) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1.2 years STANDARD_DEVIATION 0.7 | 1.4 years STANDARD_DEVIATION 0.5 | 0.7 years STANDARD_DEVIATION 0.5 | 0.6 years STANDARD_DEVIATION 0.1 | 1.6 years STANDARD_DEVIATION 0.3 | 4.0 years STANDARD_DEVIATION 0.8 | 2.9 years STANDARD_DEVIATION 0.1 | 4.0 years STANDARD_DEVIATION 1.7 | 3.9 years STANDARD_DEVIATION 1.8 | 3.7 years STANDARD_DEVIATION 1 | 9.3 years STANDARD_DEVIATION 1.2 | 9.7 years STANDARD_DEVIATION 2.3 | 10.0 years STANDARD_DEVIATION 0 | 9.0 years STANDARD_DEVIATION 1 | 9.2 years STANDARD_DEVIATION 1.5 | 15.7 years STANDARD_DEVIATION 0.6 | 13.7 years STANDARD_DEVIATION 2.1 | 14.0 years STANDARD_DEVIATION 1.8 | 15.5 years STANDARD_DEVIATION 0.7 | 13.0 years STANDARD_DEVIATION 1.7 | 6.9 years STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 32 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 0 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 3 | 2 / 3 | 1 / 3 | 3 / 3 | 2 / 4 | 2 / 4 | 1 / 3 | 2 / 3 | 2 / 3 | 4 / 5 | 2 / 3 | 3 / 3 | 2 / 2 | 2 / 3 | 2 / 5 | 1 / 3 | 1 / 3 | 4 / 4 | 2 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 5 | 0 / 3 | 0 / 3 | 0 / 2 | 1 / 3 | 1 / 5 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 3 |
Outcome results
Primary
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Time frame: Baseline to Day 7
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 1 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 1 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 2 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 2 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 4 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 1 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 1 adverse events |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 1 adverse events |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 1 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 2 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 1 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 4 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 5 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 5 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 3 adverse events |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 13 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 2 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 3 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 3 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 3 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 2 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 5 adverse events |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 2 adverse events |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 1 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 2 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 1 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 1 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 11 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 4 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 3 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 2 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Moderate | 0 adverse events |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Mild | 0 adverse events |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment | Severe | 0 adverse events |
Primary
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Time frame: Day 8 up to 28 days after open-label dose of study medication
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 1 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 2 adverse events |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 1 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 1 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 1 adverse events |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 1 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 1 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 1 adverse events |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 1 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 1 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 1 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Moderate | 0 adverse events |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Severe | 0 adverse events |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment | Mild | 0 adverse events |
Secondary
28-Day Seizure Frequency Rate
Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)\*28.
Time frame: Baseline up to 7 days post-last dose of study medication
Population: Results are not reported since the data was reported in individual participant listings but not summarized for analysis.
Secondary
Apparent Oral Clearance (CL/F): Multiple-Dose Analysis
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 19.00 milliliter/minute (mL/min) | Geometric Coefficient of Variation 10 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 17.70 milliliter/minute (mL/min) | Geometric Coefficient of Variation 47 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 18.54 milliliter/minute (mL/min) | Geometric Coefficient of Variation 49 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | NA milliliter/minute (mL/min) | — |
| Placebo (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 34.18 milliliter/minute (mL/min) | Geometric Coefficient of Variation 61 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | NA milliliter/minute (mL/min) | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | NA milliliter/minute (mL/min) | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 30.49 milliliter/minute (mL/min) | Geometric Coefficient of Variation 9 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 58.23 milliliter/minute (mL/min) | Geometric Coefficient of Variation 42 |
| Placebo (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 49.49 milliliter/minute (mL/min) | Geometric Coefficient of Variation 19 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 63.7 milliliter/minute (mL/min) | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | NA milliliter/minute (mL/min) | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 90.56 milliliter/minute (mL/min) | Geometric Coefficient of Variation 26 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 78.38 milliliter/minute (mL/min) | Geometric Coefficient of Variation 12 |
| Placebo (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 85.87 milliliter/minute (mL/min) | Geometric Coefficient of Variation 17 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis | 73.1 milliliter/minute (mL/min) | — |
Secondary
Apparent Oral Clearance (CL/F): Single-Dose Analysis
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 31.5 mL/min |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 24.7 mL/min |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 20.1 mL/min |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 28.0 mL/min |
| Placebo (Age Cohort: 1 to 23 Months) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 32.3 mL/min |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 60.1 mL/min |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 38.8 mL/min |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 45.5 mL/min |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 58.2 mL/min |
| Placebo (Age Cohort: 2 to 6 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 45.8 mL/min |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 64.8 mL/min |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 54.3 mL/min |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 99.6 mL/min |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Apparent Oral Clearance (CL/F): Single-Dose Analysis | 90.0 mL/min |
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis
Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
Population: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 7.614 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 19 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 7.563 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 26 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 7.595 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 6 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | NA (microgram*hour/milliliter)/(mg/kg) | — |
| Placebo (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 7.962 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 29 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | NA (microgram*hour/milliliter)/(mg/kg) | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | NA (microgram*hour/milliliter)/(mg/kg) | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 8.203 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 31 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 11.64 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 29 |
| Placebo (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 9.571 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 9 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 7.59 (microgram*hour/milliliter)/(mg/kg) | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | NA (microgram*hour/milliliter)/(mg/kg) | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 10.20 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 13 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 13.07 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 34 |
| Placebo (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 9.642 (microgram*hour/milliliter)/(mg/kg) | Geometric Coefficient of Variation 44 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis | 14.4 (microgram*hour/milliliter)/(mg/kg) | — |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 6.70 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 8.10 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 7.05 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 7.02 (microgram*hour/milliliter)/(mg/kg) |
| Placebo (Age Cohort: 1 to 23 Months) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 8.30 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 6.38 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 8.76 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 9.16 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 10.0 (microgram*hour/milliliter)/(mg/kg) |
| Placebo (Age Cohort: 2 to 6 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 10.1 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 8.00 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 15.9 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 13.8 (microgram*hour/milliliter)/(mg/kg) |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis | 10.6 (microgram*hour/milliliter)/(mg/kg) |
Secondary
Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis
Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.468 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 23 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.577 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 11 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.496 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 14 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | NA (microgram/milliliter)/(mg/kg) | — |
| Placebo (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.601 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 13 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | NA (microgram/milliliter)/(mg/kg) | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | NA (microgram/milliliter)/(mg/kg) | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.856 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 15 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 2.350 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 29 |
| Placebo (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.660 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 13 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 0.945 (microgram/milliliter)/(mg/kg) | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | NA (microgram/milliliter)/(mg/kg) | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.762 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 22 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 2.538 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 44 |
| Placebo (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.355 (microgram/milliliter)/(mg/kg) | Geometric Coefficient of Variation 59 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis | 1.94 (microgram/milliliter)/(mg/kg) | — |
Secondary
Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis
Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.51 (microgram/milliliter)/(mg/kg) |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.81 (microgram/milliliter)/(mg/kg) |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.18 (microgram/milliliter)/(mg/kg) |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.52 (microgram/milliliter)/(mg/kg) |
| Placebo (Age Cohort: 1 to 23 Months) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.93 (microgram/milliliter)/(mg/kg) |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.50 (microgram/milliliter)/(mg/kg) |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.70 (microgram/milliliter)/(mg/kg) |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.54 (microgram/milliliter)/(mg/kg) |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.31 (microgram/milliliter)/(mg/kg) |
| Placebo (Age Cohort: 2 to 6 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 2.29 (microgram/milliliter)/(mg/kg) |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.24 (microgram/milliliter)/(mg/kg) |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.28 (microgram/milliliter)/(mg/kg) |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.81 (microgram/milliliter)/(mg/kg) |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis | 1.79 (microgram/milliliter)/(mg/kg) |
Secondary
Number of Participants With Clinically Significant Change in Physical and Neurological Findings
Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.
Time frame: Baseline up to 7 days post-last dose of study medication
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Placebo (Age Cohort: 1 to 23 Months) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 1 participants |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Placebo (Age Cohort: 2 to 6 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 1 participants |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 1 participants |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 1 participants |
| Placebo (Age Cohort: 7 to 11 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 1 participants |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
| Placebo (Age Cohort: 12 to 16 Years) | Number of Participants With Clinically Significant Change in Physical and Neurological Findings | 0 participants |
Secondary
Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 4.433 hours | Standard Deviation 0.17559 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 3.397 hours | Standard Deviation 0.58603 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 3.263 hours | Standard Deviation 0.49903 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | NA hours | — |
| Placebo (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 3.90 hours | — |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | NA hours | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 3.523 hours | Standard Deviation 0.25146 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 3.520 hours | Standard Deviation 0.91804 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 4.287 hours | Standard Deviation 0.27737 |
| Placebo (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 4.113 hours | Standard Deviation 0.25891 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | NA hours | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | NA hours | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 4.960 hours | Standard Deviation 1.3857 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 3.953 hours | Standard Deviation 0.80532 |
| Placebo (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 5.643 hours | Standard Deviation 0.88921 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis | 6.61 hours | — |
Secondary
Plasma Decay Half-Life (t1/2): Single-Dose Analysis
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 2.64 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.78 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.76 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.22 hours |
| Placebo (Age Cohort: 1 to 23 Months) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.88 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 2.70 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.83 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.08 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 4.77 hours |
| Placebo (Age Cohort: 2 to 6 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 4.02 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.13 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 6.54 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 5.80 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Plasma Decay Half-Life (t1/2): Single-Dose Analysis | 3.85 hours |
Secondary
Renal Clearance (CLr): Multiple-Dose Analysis
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for some of the groups since none of the participant had PK parameter available in these groups.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Renal Clearance (CLr): Multiple-Dose Analysis | 21.0 mL/min | — |
| Placebo (Age Cohort: 1 to 23 Months) | Renal Clearance (CLr): Multiple-Dose Analysis | 8.77 mL/min | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | 48.4 mL/min | — |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | 11.5 mL/min | — |
| Placebo (Age Cohort: 2 to 6 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | 24.75 mL/min | Geometric Coefficient of Variation 88 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | 55.9 mL/min | — |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | 36.9 mL/min | — |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | NA mL/min | — |
| Placebo (Age Cohort: 7 to 11 Years) | Renal Clearance (CLr): Multiple-Dose Analysis | 69.16 mL/min | Geometric Coefficient of Variation 39 |
Secondary
Renal Clearance (CLr): Single-Dose Analysis
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).
Time frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are only reported for pregabalin 15 mg/kg/day, 7 to 11 years and pregabalin 5 mg/kg/day, 12 to 16 years because none of the participant had PK parameter available in rest of the groups.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Renal Clearance (CLr): Single-Dose Analysis | 42.6 mL/min |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Renal Clearance (CLr): Single-Dose Analysis | 73.8 mL/min |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis
Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 0.617 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 1.05 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 1.12 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 2.49 hours |
| Placebo (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 0.500 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 1.67 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 2.62 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 1.00 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 0.583 hours |
| Placebo (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 1.00 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 4.00 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 0.790 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 0.500 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 0.583 hours |
| Placebo (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 2.09 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis | 2.15 hours |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis
Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
Population: PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.00 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 0.967 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.13 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.00 hours |
| Placebo (Age Cohort: 1 to 23 Months) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 0.450 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.00 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.00 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.98 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.00 hours |
| Placebo (Age Cohort: 2 to 6 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 0.583 hours |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 2.00 hours |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 4.00 hours |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 4.05 hours |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis | 1.00 hours |