Switching from LEV to Brivaracetam in Patients with Epilepsy Phase III

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Single-arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam due to Nonpsychotic Behavioral Side Effects

• IRAS ID

  104261

• Contact name

  Markus Reuber

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2011-005177-23

• Research summary

  PHASE 3 TO EVALUATE THE REDUCTION IN NON-PSYCHOTIC BEHAVIOURAL UNWANTED EFFECTS IN PATIENTS WITH EPILEPSY SWITCHING FROM LEVETIRACETAM TO BRIVARACETAM. 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 evaluate if patients who suffer from epilepsy can have less unwanted reactions related to their behaviour if they switch to brivaracetam treatment 200mg/day (study medication) after stopping treatment with levetiracetam 1g/day to 3g/day (standard medication) because of these behavioural unwanted reactions. These behavioural symptoms are aggression, agitation, anger, anxiety, feeling indifferent, depression hostility, irritability, etc. All these symptoms are known as non-psychotic behavioural symptoms. The study will be conducted across approximately 30 centres in USA and Europe and approximately 100 patients will take part. Doctors in the Neurology Departments of NHS hospitals will be treating participants in the United Kingdom. Eligible patients will be asked to stop standard levetiracetam treatment and switch to study medication, brivaracetam. They will be on open treatment, which means researchers and participants know which medication is being used. Participation will include maximum 1 week screening, 12 weeks treatment period followed by 1-4 weeks down-titration period and a 2-week study medication free period. The maximum duration of the study will be up to 19 weeks, with a maximum of 16 weeks exposure to brivaracetam. There may be the option of the patient moving into a long-term follow-up study (N01372). 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/0248

• Date of REC Opinion

  27 Sep 2012

• REC opinion

  Further Information Favourable Opinion