ARISE: pAdsevonil in drug-ResIStant Epilepsy
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects with Drug- Resistant Epilepsy
IRAS ID
239564
Contact name
Manoj Satyavarapu
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2017-003200-48
Clinicaltrials.gov Identifier
135622, IND number
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
Epilepsy is a disorder of the nervous system, characterised by unprovoked seizures. More than 40 million people suffer from epilepsy. This is about 1% of the world’s population. There are different types of epileptic seizures that someone with epilepsy may suffer from. The partial-onset seizures affects only a part of the brain; the sufferer usually retains certain level of consciousness. Partial-onset seizures are often one that precedes and indicates the approach to more severe seizures that spread to larger areas of the brain.
Almost all the patients with epilepsy require appropriate medication. In the past decade, several new options for the treatment of epilepsy have been introduced, including novel anti-epileptic drugs (AEDs). However, more than 30% of patients have inadequate seizure control on currently available AEDs, therefore a need remains for AEDs with improved effectiveness and tolerability. Certain forms of epileptic seizures, not responding well to AEDs might be amenable for neurosurgical treatment.
Padsevonil is the study drug developed by UCB Biopharma SPRL.UCB is sponsoring the study to investigate the effectiveness of the study drug given in addition to current epilepsy treatment. The study also aims to see how safe padsevonil is and how well participant body can tolerate it. Padsevonil is designed to better control seizures in patients who are resistant to other therapies (i.e., who have not had complete seizure control with other drugs and/or devices). In this study the first clinical data of the potential seizure control will be collected as well.
This is a randomised, double blind, study meaning that neither the patient nor the study doctor will know which medication is being given.This is a multicentre study which will take place in approximately 15 countries. It is anticipated that approximately 300 participants will be recruited across 140 study sites worldwide.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0063
Date of REC Opinion
9 Apr 2018
REC opinion
Further Information Favourable Opinion