Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00437281
Collaborator
(none)
65
18
2
67.1
3.6
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures
Study Start Date
:
Apr 1, 2007
Actual Primary Completion Date
:
Nov 1, 2012
Actual Study Completion Date
:
Nov 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
| Experimental: Pregabalin
|
Drug: Pregabalin
Orally-administered pregabalin
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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).
- 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).
- 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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Month
to 16 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Mobile | Alabama | United States | 36604 |
| 2 | Pfizer Investigational Site | Mobile | Alabama | United States | 36693 |
| 3 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85016 |
| 4 | Pfizer Investigational Site | Jonesboro | Arkansas | United States | 72401 |
| 5 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 6 | Pfizer Investigational Site | San Francisco | California | United States | 94143 |
| 7 | Pfizer Investigational Site | Gulf Breeze | Florida | United States | 32561 |
| 8 | Pfizer Investigational Site | Pensacola | Florida | United States | 32504 |
| 9 | Pfizer Investigational Site | Tampa | Florida | United States | 33603 |
| 10 | Pfizer Investigational Site | Tampa | Florida | United States | 33609 |
| 11 | Pfizer Investigational Site | Springfield | Missouri | United States | 65804 |
| 12 | Pfizer Investigational Site | Buffalo | New York | United States | 14222 |
| 13 | Pfizer Investigational Site | Durham | North Carolina | United States | 27710 |
| 14 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 15 | Pfizer Investigational Site | San Antonio | Texas | United States | 78258 |
| 16 | Pfizer Investigational Site | Seoul | Korea, Republic of | 120-752 | |
| 17 | Pfizer Investigational Site | Mexico | DF | Mexico | 06720 |
| 18 | Pfizer Investigational Site | Guadalajara | Jalisco | Mexico | 44280 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00437281
Other Study ID Numbers:
- A0081074
First Posted:
Feb 19, 2007
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2014
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Period Title: Overall Study | ||||||||||||||||||||
| STARTED | 3 | 3 | 3 | 3 | 4 | 4 | 3 | 3 | 3 | 5 | 3 | 3 | 2 | 3 | 5 | 3 | 3 | 4 | 2 | 3 |
| COMPLETED | 3 | 3 | 3 | 2 | 4 | 3 | 3 | 3 | 3 | 4 | 3 | 3 | 2 | 2 | 4 | 3 | 3 | 4 | 1 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 3 | 3 | 3 | 3 | 4 | 4 | 3 | 3 | 3 | 5 | 3 | 3 | 2 | 3 | 5 | 3 | 3 | 4 | 2 | 3 | 65 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||||||||||||||
| Mean (Standard Deviation) [years] |
1.2
(0.7)
|
1.4
(0.5)
|
0.7
(0.5)
|
0.6
(0.1)
|
1.6
(0.3)
|
4.0
(0.8)
|
2.9
(0.1)
|
4.0
(1.7)
|
3.9
(1.8)
|
3.7
(1.0)
|
9.3
(1.2)
|
9.7
(2.3)
|
10.0
(0.0)
|
9.0
(1.0)
|
9.2
(1.5)
|
15.7
(0.6)
|
13.7
(2.1)
|
14.0
(1.8)
|
15.5
(0.7)
|
13.0
(1.7)
|
6.9
(5.2)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||||||||||
| Female |
1
33.3%
|
2
66.7%
|
1
33.3%
|
2
66.7%
|
2
50%
|
4
100%
|
2
66.7%
|
1
33.3%
|
1
33.3%
|
3
60%
|
2
66.7%
|
1
33.3%
|
0
0%
|
0
0%
|
4
80%
|
2
66.7%
|
1
33.3%
|
0
0%
|
0
0%
|
3
100%
|
32
49.2%
|
| Male |
2
66.7%
|
1
33.3%
|
2
66.7%
|
1
33.3%
|
2
50%
|
0
0%
|
1
33.3%
|
2
66.7%
|
2
66.7%
|
2
40%
|
1
33.3%
|
2
66.7%
|
2
100%
|
3
100%
|
1
20%
|
1
33.3%
|
2
66.7%
|
4
100%
|
2
100%
|
0
0%
|
33
50.8%
|
Outcome Measures
| Title | Number of Participants With Clinically Significant Change in Physical and Neurological Findings |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all participants who received at least 1 dose of study medication. |
| Arm/Group Title | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 3 | 4 | 4 | 3 | 3 | 3 | 5 | 3 | 3 | 2 | 3 | 5 | 3 | 3 | 4 | 2 | 3 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
1
50%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
| Title | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all participants who received at least 1 dose of study medication. |
| Arm/Group Title | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 3 | 4 | 4 | 3 | 3 | 3 | 5 | 3 | 3 | 2 | 3 | 5 | 3 | 3 | 4 | 2 | 3 |
| Mild |
0
|
2
|
2
|
4
|
1
|
1
|
4
|
5
|
5
|
13
|
0
|
3
|
3
|
5
|
2
|
0
|
2
|
11
|
2
|
0
|
| Moderate |
1
|
1
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
3
|
2
|
0
|
0
|
2
|
0
|
1
|
1
|
4
|
3
|
0
|
| Severe |
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
| Title | 28-Day Seizure Frequency Rate |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Results are not reported since the data was reported in individual participant listings but not summarized for analysis. |
| Arm/Group Title | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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) | 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) | 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) | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants of 1 to 23 months 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 2 | 3 | 2 | 2 | 3 | 3 | 3 | 1 | 2 | 3 | 3 | 4 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [(microgram*hour/milliliter)/(mg/kg)] |
7.614
(19)
|
7.563
(26)
|
7.595
(6)
|
NA
(NA)
|
7.962
(29)
|
NA
(NA)
|
NA
(NA)
|
8.203
(31)
|
11.64
(29)
|
9.571
(9)
|
7.59
|
NA
(NA)
|
10.20
(13)
|
13.07
(34)
|
9.642
(44)
|
14.4
|
| Title | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | Participants of 7 to 11 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 7 to 11 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 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 12 to 16 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 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [(microgram*hour/milliliter)/(mg/kg)] |
6.70
|
8.10
|
7.05
|
7.02
|
8.30
|
6.38
|
8.76
|
9.16
|
10.0
|
10.1
|
8.00
|
15.9
|
13.8
|
10.6
|
| Title | Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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) | 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) | 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) | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants of 1 to 23 months 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 2 | 3 | 2 | 2 | 3 | 3 | 3 | 1 | 2 | 3 | 3 | 4 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [(microgram/milliliter)/(mg/kg)] |
1.468
(23)
|
1.577
(11)
|
1.496
(14)
|
NA
(NA)
|
1.601
(13)
|
NA
(NA)
|
NA
(NA)
|
1.856
(15)
|
2.350
(29)
|
1.660
(13)
|
0.945
|
NA
(NA)
|
1.762
(22)
|
2.538
(44)
|
1.355
(59)
|
1.94
|
| Title | Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | Participants of 7 to 11 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 7 to 11 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 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 12 to 16 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 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [(microgram/milliliter)/(mg/kg)] |
1.51
|
1.81
|
1.18
|
1.52
|
1.93
|
1.50
|
1.70
|
1.54
|
1.31
|
2.29
|
1.24
|
1.28
|
1.81
|
1.79
|
| Title | Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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) | 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) | 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) | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants of 1 to 23 months 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 2 | 3 | 2 | 2 | 3 | 3 | 3 | 1 | 2 | 3 | 3 | 4 | 1 |
| Median (Full Range) [hours] |
0.617
|
1.05
|
1.12
|
2.49
|
0.500
|
1.67
|
2.62
|
1.00
|
0.583
|
1.00
|
4.00
|
0.790
|
0.500
|
0.583
|
2.09
|
2.15
|
| Title | Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | Participants of 7 to 11 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 7 to 11 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 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 12 to 16 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 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Median (Full Range) [hours] |
1.00
|
0.967
|
1.13
|
1.00
|
0.450
|
1.00
|
1.00
|
1.98
|
1.00
|
0.583
|
2.00
|
4.00
|
4.05
|
1.00
|
| Title | Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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) | 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) | 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) | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants of 1 to 23 months 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 2 | 1 | 2 | 3 | 3 | 3 | 3 | 2 | 2 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [hours] |
4.433
(0.17559)
|
3.397
(0.58603)
|
3.263
(0.49903)
|
NA
(NA)
|
3.90
|
NA
(NA)
|
3.523
(0.25146)
|
3.520
(0.91804)
|
4.287
(0.27737)
|
4.113
(0.25891)
|
NA
(NA)
|
NA
(NA)
|
4.960
(1.3857)
|
3.953
(0.80532)
|
5.643
(0.88921)
|
6.61
|
| Title | Plasma Decay Half-Life (t1/2): Single-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | Participants of 7 to 11 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 7 to 11 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 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 12 to 16 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 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Mean (Standard Deviation) [hours] |
2.64
|
3.78
|
3.76
|
3.22
|
3.88
|
2.70
|
3.83
|
3.08
|
4.77
|
4.02
|
3.13
|
6.54
|
5.80
|
3.85
|
| Title | Apparent Oral Clearance (CL/F): Multiple-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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) | 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) | 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) | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants of 1 to 23 months 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 2 | 3 | 2 | 2 | 3 | 3 | 3 | 1 | 2 | 3 | 3 | 4 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [milliliter/minute (mL/min)] |
19.00
(10)
|
17.70
(47)
|
18.54
(49)
|
NA
(NA)
|
34.18
(61)
|
NA
(NA)
|
NA
(NA)
|
30.49
(9)
|
58.23
(42)
|
49.49
(19)
|
63.7
|
NA
(NA)
|
90.56
(26)
|
78.38
(12)
|
85.87
(17)
|
73.1
|
| Title | Apparent Oral Clearance (CL/F): Single-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | Participants of 7 to 11 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 7 to 11 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 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 12 to 16 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 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/min] |
31.5
|
24.7
|
20.1
|
28.0
|
32.3
|
60.1
|
38.8
|
45.5
|
58.2
|
45.8
|
64.8
|
54.3
|
99.6
|
90.0
|
| Title | Renal Clearance (CLr): Multiple-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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) | 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) | 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) | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants of 1 to 23 months 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 3 | 1 | 1 | 0 | 2 | 3 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/min] |
21.0
|
8.77
|
48.4
|
11.5
|
24.75
(88)
|
55.9
|
36.9
|
NA
(NA)
|
69.16
(39)
|
| Title | Renal Clearance (CLr): Single-Dose Analysis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years) | Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | 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 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | 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 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. | Participants of 7 to 11 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 7 to 11 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 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 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 on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week. | Participants of 12 to 16 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 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. | Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 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. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/min] |
42.6
|
73.8
|
| Title | Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all participants who received at least 1 dose of study medication. |
| Arm/Group Title | 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) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 3 | 3 | 3 | 3 | 4 | 4 | 3 | 3 | 3 | 5 | 3 | 3 | 2 | 3 | 5 | 3 | 3 | 4 | 2 | 3 |
| Mild |
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
| Moderate |
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
| Severe |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
Adverse Events
| Time Frame | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||||||||||||||||||||||||||||||||||||
| Arm/Group Title | 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) | ||||||||||||||||||||
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | ||||||||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||||||||||||
| 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) | |||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||||||||||||
| 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) | |||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||||||
| Ataxia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Convulsion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Somnolence | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||||||||||
| 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) | |||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) | 2/4 (50%) | 2/4 (50%) | 1/3 (33.3%) | 2/3 (66.7%) | 2/3 (66.7%) | 4/5 (80%) | 2/3 (66.7%) | 3/3 (100%) | 2/2 (100%) | 2/3 (66.7%) | 2/5 (40%) | 1/3 (33.3%) | 1/3 (33.3%) | 4/4 (100%) | 2/2 (100%) | 0/3 (0%) | ||||||||||||||||||||
| Eye disorders | ||||||||||||||||||||||||||||||||||||||||
| Mydriasis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||||||
| Constipation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Diarrhoea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/5 (40%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Dry mouth | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Nausea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||||||||||
| Vomiting | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||||||||||||
| Chest pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Fatigue | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Feeling abnormal | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Gait disturbance | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Irritability | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Oedema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Oedema peripheral | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Pyrexia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 2/5 (40%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Immune system disorders | ||||||||||||||||||||||||||||||||||||||||
| Seasonal allergy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Infections and infestations | ||||||||||||||||||||||||||||||||||||||||
| Otitis media | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Subcutaneous abscess | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Upper respiratory tract infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Viral infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Investigations | ||||||||||||||||||||||||||||||||||||||||
| Electrocardiogram abnormal | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Platelet count decreased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Tandem gait test abnormal | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||||||||||
| Decreased appetite | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||||||||||
| Muscular weakness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||||||
| Ataxia | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Balance disorder | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||||||||||
| Convulsion | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Dizziness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 2/3 (66.7%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 2/4 (50%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||||||||||
| Drooling | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Headache | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Hypersomnia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Lethargy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Mental impairment | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Nystagmus | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Psychomotor hyperactivity | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Sedation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Somnolence | 0/3 (0%) | 2/3 (66.7%) | 0/3 (0%) | 2/3 (66.7%) | 2/4 (50%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 2/3 (66.7%) | 1/3 (33.3%) | 0/2 (0%) | 1/3 (33.3%) | 0/5 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||||||||||
| Speech disorder | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||||||||||||||||||
| Insomnia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Learning disorder | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||||||||||
| Nasal congestion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Rhonchi | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Sinus congestion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Snoring | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Wheezing | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||||||
| Dermatitis contact | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Dermatitis diaper | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Erythema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Pruritus | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Rash | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
| Vascular disorders | ||||||||||||||||||||||||||||||||||||||||
| Flushing | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/5 (0%) | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||||||||||
Limitations/Caveats
Results are reported for AUCtau for multiple-dose PK analysis and AUC (0-∞) for single-dose PK analysis, instead of AUC (0-24), as per change in planned analysis.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00437281
Other Study ID Numbers:
- A0081074
First Posted:
Feb 19, 2007
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2014