Status:
COMPLETED
A Study of Brivaracetam in Subjects With Partial Onset Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy, Focal
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy
Eligibility Criteria
Inclusion
- Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- Subjects with a history of partial onset seizures
- Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
- Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
- Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted
Exclusion
- Seizure type IA non-motor as only seizure type
- History or presence of seizures occurring only in clustered patterns
- History of cerebrovascular accident (CVA)
- Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00175929
Start Date
May 1 2005
End Date
March 1 2006
Last Update
April 13 2015
Active Locations (56)
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1
Bruges, Belgium
2
Brussels, Belgium
3
Duffel, Belgium
4
Edegem, Belgium