A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 10/4/2018 |
| Start Date: | November 7, 2005 |
| End Date: | June 29, 2006 |
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
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.
mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
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
We found this trial at
27
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