NCT00772603

Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Detailed description

Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	Placebo	Non-active tablet identical to study drug tablets
DRUG	2400mg SPN-804	tablets containing 600mg OXC XR, identical to non-active tablets
DRUG	1200mg SPN-804	two active tablets and two non-active tablets, all identical

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-04-01
• Completion: 2010-11-01
• First posted: 2008-10-15
• Last updated: 2014-02-11
• Results posted: 2014-02-11

Locations

71 sites across 8 countries: United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, Russia