Status:
TERMINATED
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
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief Summary
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 B...
Eligibility Criteria
Inclusion
- 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
- Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose
Exclusion
- Seizure type IA non-motor as only seizure type
- History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
- Other serious uncontrolled disease
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00699283
Start Date
August 1 2008
End Date
March 1 2010
Last Update
July 11 2018
Active Locations (68)
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1
Little Rock, Arkansas, United States
2
Garden Grove, California, United States
3
Loma Linda, California, United States
4
Newport Beach, California, United States