ARISE (pAdsevonil in dRug-ResIStant Epilepsy)
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
This study focuses on evaluating the efficacy and safety of a drug on adults who suffer from focal-onset seizures with diagnosed drug-resistant epilepsy.
This drug focuses on adults whose seizures are not well controlled with the treatment they are on and serves as an add on drug.
These adults have continued to have uncontrolled focal-onset seizure despite treatment with at least 4 prior AED regimens.
Those taking GABA-A-ergic AEDs will be able to participate, but those taking Gaba-A-ergic drugs (Agonists (barbiturates) or Allosteric modulators (BSDs or non BZDs) more than twice a week are not able to participate.
This drug will be compared to a placebo, which is a drug that appears similar to the study drug, but does not contain the active ingredients.
The study will be conducted over a 24 week period and includes study visits to the site as required by the doctor.
You will be compensated for your time and participation.