A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Status:	Terminated
Conditions:	Neurology, Epilepsy
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	16 - 75
Updated:	7/13/2018
Start Date:	August 2008
End Date:	February 2010

An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited
number of AEDs are approved for use as monotherapy. The objective of this study is to
evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure
patients from combination treatment to monotherapy

Inclusion Criteria:

- Subjects from 16 to 75 years, both inclusive

- Well-characterized focal epilepsy or epileptic syndrome

- Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not
secondarily generalized per 4 weeks during the 8-week Baseline Period

- Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic
Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose

Exclusion Criteria:

- Seizure type IA non-motor as only seizure type

- History or presence of seizures occurring too frequently or indistinctly separated to
be reliably counted during the 6 months preceding Visit 1 or during Baseline

- Other serious uncontrolled disease

We found this trial at

sites

Clinical Trial Facility in Summit New Jersey

Summit, New Jersey 07901

from

Summit, NJ