Status:
COMPLETED
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
Eligibility Criteria
Inclusion
- Male/female from 16 to 65 years
- Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- History of partial onset seizures
- Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
- Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.
Exclusion
- Seizure type IA non-motor as only seizure type
- Seizures occurring only in clusters
- Status epilepticus during the last 2 years before Visit 1
- History of cerebrovascular accident (CVA)
- Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Key Trial Info
Start Date :
November 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2006
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00175825
Start Date
November 7 2005
End Date
June 29 2006
Last Update
October 2 2018
Active Locations (42)
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1
Phoenix, Arizona, United States
2
Little Rock, Arkansas, United States
3
Fresno, California, United States
4
Bradenton, Florida, United States