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

UCB

Status and phase

Terminated

Phase 3

Conditions

Epilepsy

Treatments

Drug: Brivaracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00698581

N01276

2008-000144-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

88 patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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