At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 482 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 450 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.
A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Oct 2, 2007·Updated Jan 22, 2021
In Brief
A Phase 4 clinical trial evaluating Pregabalin and Gabapentin for Epilepsy and 3 related conditions. Completed, enrolled 482 participants across 8 sites in 4 countries.
Detailed Summary
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCosta Rica, El Salvador, Guatemala, Peru
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartFeb 2008
Primary CompletionJul 2013
TodayJul 2026
First PostedOct 2, 2007
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.8 years ago
Interventions
Pregabalindrug
150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
Gabapentindrug
300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects