Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - 70
Updated:8/10/2018
Start Date:September 2007
End Date:January 2009

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An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures

This study will evaluate the efficacy and safety of Brivaracetam to support the submission
file in the indication of adjunctive treatment in adolescents and adults with partial onset
seizures.


Inclusion Criteria:

- Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only
included where legally permitted and ethically accepted

- Subjects with well-characterized focal epilepsy or epileptic syndrome according to the
International League Against Epilepsy (ILAE) classification

- Subjects had a history of partial onset seizures (POS) whether or not secondarily
generalized (Type I seizures according to the ILAE classification)

- Subjects had at least 2 POS whether or not secondarily generalized per month during
the 3 months preceding Visit 1 (V1)

- Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week
Baseline Period

- Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic
drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a
concomitant AED

Exclusion Criteria:

- History or presence of seizures occurring only in clusters (too frequently or
indistinctly separated to be reliably counted) before Visit 3

- History or presence of status epilepticus during the year preceding Visit 1 or during
Baseline
We found this trial at
41
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