VX11-765-402 Study of VX-765 in epilepsy patients
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment-Resistant Partial Epilepsy
IRAS ID
100914
Contact name
Martin J Brodie
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2011-004156-19
Clinicaltrials.gov Identifier
Research summary
This study will look at the safety, tolerability and effectiveness of the anti-epileptic drug (AED) VX-765 in patients with partial epilepsy that has been resistant to treatment. Epilepsy has serious health and life style consequences for patients. At least 30% of patients with epilepsy do not respond to their medicine even if receiving several different types. For this reason new drugs with new modes of action could change the lives of patients with treatment-resistant epilepsy. Increased ICE (interleukin converting enzyme) levels may be a cause of epilepsy. VX-765 is an ICE inhibitor which means it stops the action of ICE and therefore it may be suitable for treating epilepsy. Up to 500 patients will be recruited for this global study. There will be an equal number of patients in each of the 5 treatment groups. Patients will receive one of four doses of VX-765 or placebo (a dummy tablet that looks like VX-765 but has no active ingredient). This is a double-blind study which means that neither the patient nor the study doctor will know the dose of study drug assigned. Patients will be randomly sorted (by chance) into treatment groups before the first dose of study drug according to the average number of seizures each week of the Baseline period. A 56 day Screening period is followed by a 13 week Treatment Period. Study assessments will be done by clinic visits and telephone contacts: Physical and neurological examinations, vital signs, ECGs, blood and urine tests and patient diary for seizure frequency. 50 patients at selected sites will have additional PK blood samples taken to measure levels of VX-765 in the blood at specified time points. After completion of the Treatment Period patients may participate in an extension study and continue to receive VX-765 or will attend for the safety follow-up visit.
REC name
West of Scotland REC 1
REC reference
12/WS/0052
Date of REC Opinion
9 Jul 2012
REC opinion
Further Information Favourable Opinion