Trials / Completed
CompletedNCT01747915
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 219 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 5 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pregabalin Dose Level 1 | Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination. |
| DRUG | Pregabalin Dose Level 2 | Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination. |
| DRUG | Placebo | Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination. |
Timeline
- Start date
- 2013-04-03
- Primary completion
- 2019-02-20
- Completion
- 2019-02-20
- First posted
- 2012-12-12
- Last updated
- 2021-01-20
- Results posted
- 2019-08-28
Locations
127 sites across 26 countries: United States, Austria, Belarus, Bosnia and Herzegovina, Bulgaria, China, Croatia, Denmark, France, Greece, Hungary, India, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01747915. Inclusion in this directory is not an endorsement.