Open Label Brivaracetam Study in Patients with Epilepsy

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Partial Onset Seizures

• IRAS ID

  73661

• Sponsor organisation

  UCB Biosciences, Inc.

• Eudract number

  2010-020345-27

• ISRCTN Number

  N/A

• Research summary

  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 evaluate the long term safety and tolerability of brivaracetam at individualised doses up to a maximum 200 mg per day, in treating patients diagnosed with focal epilepsy with partial onset seizures (POS - 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 participants who are finished the treatment period of N01358 study to be invited into this study. It is an open label study, which means that the doctor and the participant know which treatment they have been assigned to. Upon completion or early discontinuation the participants will undergo a Down-Titration Period, followed by a Posttreatment Period, during these the participants will not receive study medication.The study will run during the clinical development of brivaracetam, and will continue until the marketing authorisation is granted by any Regulatory Agency in an indication for the adjunctive treatment in adults with refractory POS, whether or not secondary generalised, or the Sponsor decides to close the study, or until the brivaracetam development is stopped by the Sponsor.The study will be carried out in Canada, USA, Latin America, Western Europe, Eastern Europe, Asia and Africa and approximately 650 - 720 patients will be invited to participate in this study, based on the assumption that at least 90% of participants completed the N01358 study. Doctors in the Neurology Departments of NHS hospitals will be treating participants in the United Kingdom.The participants will start to take brivaracetam at dose of 150 mg per day (in two equally divided doses administered twice daily) and should be maintained at this dose for at least 2 weeks unless the participant's unable to tolerate the treatment. The brivaracetam dose can be adjusted based on control of seizures and tolerability. The brivaracetam dose may not exceed 200 mg per day during the study and must always be administered as a symmetrical morning and evening dose.Participants will have to undergo a physical and neurological examination, blood and urine tests, electrocardiograms (ECGs) and complete questionnaires.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  11/NE/0039

• Date of REC Opinion

  18 May 2011

• REC opinion

  Further Information Favourable Opinion