A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
Recruiting in Palo Alto (17 mi)
+67 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: UCB Pharma
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.
Research Team
UC
UCB Clinical Trial Call Center
Principal Investigator
+1 877 822 9493 (UCB)
Eligibility Criteria
Inclusion Criteria
Subjects from 16 to 75 years, both inclusive
Well-characterized focal epilepsy or epileptic syndrome
Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
See 1 more
Treatment Details
Interventions
- Brivaracetam (Antiepileptic Drug)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Brivaracetam (BRV) 2Experimental Treatment1 Intervention
100 mg daily
Group II: Brivaracetam (BRV) 1Experimental Treatment1 Intervention
50 mg daily
Brivaracetam is already approved in Canada for the following indications:
Approved in Canada as Brivlera for:
- Partial-onset seizures with or without secondary generalisation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00699283Gainesville, FL
NCT00699283Chicago, IL
NCT00699283Danville, IN
NCT00699283Ogden, UT
More Trial Locations
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Who Is Running the Clinical Trial?
UCB Pharma
Lead Sponsor
Trials
345
Patients Recruited
110,000+