Overview

A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

Status:
Completed
Trial end date:
2006-06-29
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma
Treatments:
Brivaracetam
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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