CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Pregabalin Dose Level 1 +2 moredrug
Likely dose
Pregabalin Dose Level 1 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01747915
NCT01747915Phase 3Completed
CompareCT.gov

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Dec 12, 2012·Updated Jan 20, 2021

In Brief

A Phase 3 clinical trial evaluating Pregabalin Dose Level 1, Pregabalin Dose Level 2, and 1 other intervention for Generalized Tonic Clonic Seizures. Completed, enrolled 219 participants across 127 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Tonic Clonic Seizures
CountriesAustria, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2012
Enrollment StartApr 3, 2013
Primary CompletionFeb 20, 2019
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.6 years ago

Interventions

Pregabalin Dose Level 1drug

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.

Pregabalin Dose Level 2drug

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.

Placebodrug

Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.