Extension study of Brivaracetam 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 Epilepsy

• IRAS ID

  105505

• Contact name

  Markus Reuber

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2012-000827-42

• Research summary

  PHASE 3 FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF BRIVARACETAM IN PATIENTS WITH EPILEPSY. Epilepsy is one of the most common and challenging neurological disorders affecting more than half a million people in the UK, which is around 1 in 100 people. The condition is characterised by seizures (also known as fits) caused by a sudden burst of excess electrical activity in the brain. The purpose of this study is to see how safe and effective brivaracetam (BRV) is during long term use in reducing the frequency of patient's seizures. The study will also allow patients to continue to take BRV as part of the treatment for epilepsy. This study will involve only those patients that previously participated in a BRV research study as N01394 or N01395. Additional patients who may receive BRV in other future studies that have not started yet, will also be able to take part in this study. This study will involve a total of about 650 patients across approximately 120 centres throughout North America (Canada and USA) and Europe with a possible extension to other countries or regions. Doctors in the Neurology Departments of NHS hospitals will be treating participants in the United Kingdom. Eligible patients will receive the same dose of BRV that they had reached at the completion of their previous study. Dose can be changed by study doctor between 50mg and 200mg BRV. This study will last approx. 3-4 years until the medication is approved for sale, or the development program is stopped or the Sponsor stops the study. If a patient wishes to stop participation there will be a Down-Titration period (1-4 weeks) and a Posttreatment Period (2-4 weeks). Participants will have to undergo a physical and neurological examination, blood and urine tests, electrocardiograms (ECGs) and complete questionnaires.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  12/YH/0249

• Date of REC Opinion

  27 Sep 2012

• REC opinion

  Further Information Favourable Opinion