Brivaracetam versus Placebo in Patients with Partial Onset Seizures
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (=16 To 80 Years Old) With Partial Onset Seizures
IRAS ID
66709
Sponsor organisation
UCB Biosciences, Inc.
Eudract number
2010-019361-28
Clinicaltrials.gov Identifier
Research summary
A randomised, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of brivaracetam in subjects (=16 to 80 years old) with partial onset seizures.Epilepsy is one of the most common and challenging neurological disorders affecting around 450,000 people in the UK. The condition is characterised by seizures (also known as fits) caused by a sudden burst of excess electrical activity in the brain, which temporarily disrupts the normal message passing between brain cells. The purpose of this study is to compare the effectiveness of the experimental medication, Brivaracetam, against placebo (a sugar tablet containing no active medicine) in treating patients diagnosed with focal epilepsy with partial onset seizures (seizures involving one area of cells in the brain). Focal epilepsy is the most frequently diagnosed classification of epilepsy and accounts for approximately 60-70% of all cases. The study also aims to assess the safety and tolerability (how well the participants can tolerate the study medication) of Brivaracetam.The study will be carried out in Canada, USA, Latin America, Western Europe, Eastern Europe, Asia and Africa and approximately 900 patients will be invited to participate in this study with the aim of 720 of them being eligible. Doctors in the Neurology Departments of NHS hospitals will be treating participants in the United Kingdom.Eligible patients will be randomly assigned into one of three treatment arms: brivaracetam 100mg/day; brivaracetam 200mg/day; or placebo. They will be on double-blind treatment, which means that neither the doctor nor the participant knows which treatment group they have been assigned to. Participation will last for up to 26 weeks and there may be the option of the patient moving into a long-term follow-up study.The participants will have to undergo a physical and neurological examination, possibly a computed tomography (CT) or a magnetic resonance imaging (MRI) scan if the last one is more than 2 years ago, blood and urine tests, electrocardiograms (ECGs), possibly an electroencephalogram (EEG) if the last one is more than 5 years ago and complete questionnaires.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
11/NE/0038
Date of REC Opinion
18 May 2011
REC opinion
Further Information Favourable Opinion