NCT01191086CompletedPhase 3
Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Upsher-Smith Laboratories
- Enrollment
- 210
- Primary Endpoint
- Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Study Overview
Brief Summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Open-label USL255
Experimental
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Intervention: USL255 (Drug)
Outcomes
Primary Outcomes
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Time Frame: Open label treatment of up to 62 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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