Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Recruiting in Palo Alto (17 mi)
+67 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Upsher-Smith Laboratories
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Research Team
Eligibility Criteria
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
Treatment Details
Interventions
- USL255 (Anti-epileptic drug)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-label USL255Experimental Treatment1 Intervention
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01191086Ventura, CA
NCT01191086Gainsville, FL
NCT01191086Gulf Breeze, FL
NCT01191086Chesterfield, MO
More Trial Locations
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Who Is Running the Clinical Trial?
Upsher-Smith Laboratories
Lead Sponsor
Trials
11
Patients Recruited
7,100+