Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: USL255

• Registration Number: NCT01191086
• Lead Sponsor: Upsher-Smith Laboratories

Brief Summary

The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2010-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-02
• Results First Submitted: 2015-02-09
• Results First Submitted QC: 2015-02-09
• Last Update Submitted: 2015-02-09
• Results First Posted: 2015-02-23
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Have completed the maintenance period of the P09-004 study.
• Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label USL255	USL255	Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

Primary Outcome Measures

Name	Time	Method
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations	Open label treatment of up to 62 weeks