Padsenovil for Focal Seizures in Adults with Drug-Resistant Epilepsy

• Research type

  Research Study

• Full title

  A MULTICENTRE, RANDOMISED, DOUBLE-BLIND,PLACEBO-CONTROLLED, PARALLEL-GROUP 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

  255895

• Contact name

  Daniel King

• Contact email

  Daniel.King@PAREXEL.com

• Sponsor organisation

  UCB Biopharma SPRL

• Eudract number

  2018-002303-33

• Clinicaltrials.gov Identifier

  NCT03739840

• Clinicaltrials.gov Identifier

  135622, IND Number

• Duration of Study in the UK

  1 years, 6 months, 1 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 focal epilepsy affects only a part of the brain; the sufferer usually retains certain level of consciousness. Focal epilepetic 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 a 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 555 participants will be recruited across 200 study sites worldwide.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  19/EM/0034

• Date of REC Opinion

  17 Jun 2019

• REC opinion

  Further Information Favourable Opinion