Phase 2
N=65
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
Epilepsies, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00437281 ↗Enrolled (actual)
65
Serious AEs
3.1%
Results posted
Mar 2014
Primary outcome: Primary: Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment — 0; 2; 2; 4 adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Pregabalin (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment |
0; 2; 2; 4; 1; 1 | — |
| PRIMARY Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment |
0; 0; 0; 1; 2; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Physical and Neurological Findings |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY 28-Day Seizure Frequency Rate |
— | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis |
7.614; 7.563; 7.595; NA; 7.962; NA | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis |
6.70; 8.10; 7.05; 7.02; 8.30; 6.38 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis |
1.468; 1.577; 1.496; NA; 1.601; NA | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis |
1.51; 1.81; 1.18; 1.52; 1.93; 1.50 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis |
0.617; 1.05; 1.12; 2.49; 0.500; 1.67 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis |
1.00; 0.967; 1.13; 1.00; 0.450; 1.00 | — |
| SECONDARY Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis |
4.433; 3.397; 3.263; NA; 3.90; NA | — |
| SECONDARY Plasma Decay Half-Life (t1/2): Single-Dose Analysis |
2.64; 3.78; 3.76; 3.22; 3.88; 2.70 | — |
| SECONDARY Apparent Oral Clearance (CL/F): Multiple-Dose Analysis |
19.00; 17.70; 18.54; NA; 34.18; NA | — |
| SECONDARY Apparent Oral Clearance (CL/F): Single-Dose Analysis |
31.5; 24.7; 20.1; 28.0; 32.3; 60.1 | — |
| SECONDARY Renal Clearance (CLr): Multiple-Dose Analysis |
21.0; 8.77; 48.4; 11.5; 24.75; 55.9 | — |
| SECONDARY Renal Clearance (CLr): Single-Dose Analysis |
42.6; 73.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00437281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.