Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Phase 3

Completed

• Conditions: Partial Epilepsy
• Interventions: Drug: Oxcarbazepine XR

• Registration Number: NCT00908349
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief Summary

Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Detailed Description

NAP

Study Timeline

• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Study Start: 2009-06
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2016-02-25
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-01
• Last Update Submitted: 2017-05-01
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxcarbazepine XR	Oxcarbazepine XR	Open Label Study

Primary Outcome Measures

Name	Time	Method
Percent Change in Seizure Rate	one year	Measured as change from baseline to end of study