NCT01262677

Once-A-Day Pregabalin For Partial Seizures

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Seizures
• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	pregabalin	Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
DRUG	pregabalin	Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
DRUG	pregabalin	Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
DRUG	pregabalin	Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
DRUG	pregabalin	Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
DRUG	pregabalin	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)
DRUG	placebo	matched to the active drug

Timeline

• Start date: 2011-02-17
• Primary completion: 2012-07-31
• Completion: 2012-08-01
• First posted: 2010-12-17
• Last updated: 2021-01-25
• Results posted: 2018-06-06

Locations

82 sites across 18 countries: United States, Argentina, Bosnia and Herzegovina, Bulgaria, Czechia, Germany, Hong Kong, Hungary, India, Malaysia, Mexico, Poland, Puerto Rico, Romania, Russia, Serbia, Singapore, Thailand