Overview

Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma SA
Treatments:
Brivaracetam
Criteria
Inclusion Criteria:

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

- Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy
according to the International League Against Epilepsy (ILAE) classification

- For subjects suffering from localization-related Epilepsy: subjects had at least 2
Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during
the 3 months preceding Visit 1 according to the ILAE classification

- For subjects suffering from localization-related Epilepsy: subjects had at least 4
Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week
Baseline Period according to the ILAE classification

- For subjects suffering from generalized Epilepsy: subjects had at least 2 Type
II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE
classification

- For subjects suffering from generalized Epilepsy: subjects had at least 4 Type
II-seizure days during the 4 week Baseline Period according to the ILAE classification

- Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic
Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant
AED

Exclusion Criteria:

- For subjects who suffered from localization-related Epilepsy: history or presence of
Seizures occurring only in clusters (too frequently or indistinctly separated to be
reliably counted) before Visit 2 or occurring only as Type IA non-motor

- Subjects with a history or presence of Status Epilepticus during the year preceding
Visit 1 or during Baseline