Trials / Completed
CompletedNCT02072824
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 1 Month – 3 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pregabalin Dose Level 1 | Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase |
| DRUG | Pregabalin Dose Level 2 | Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase |
| DRUG | Placebo | Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase |
Timeline
- Start date
- 2014-09-16
- Primary completion
- 2018-03-13
- Completion
- 2018-03-13
- First posted
- 2014-02-27
- Last updated
- 2021-01-20
- Results posted
- 2018-10-09
Locations
72 sites across 23 countries: United States, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, China, France, Germany, Greece, Hungary, Israel, Lebanon, Malaysia, Philippines, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02072824. Inclusion in this directory is not an endorsement.