At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures
In Brief
A Phase 3 clinical trial evaluating pregabalin and placebo for Partial Seizures and Epilepsies, Partial. Completed, enrolled 325 participants across 82 sites in 18 countries.
Detailed Summary
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.
Study Details
Timeline
Interventions
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
matched to the active drug