Padsevonil as adjunctive treatment of focal-onset seizures

Recruiting

18 years - 90 years

All

Phase 2

10 participants needed

1 Location

Brief description of study

You are being asked to participate in this clinical research study because you have epilepsy associated with focal onset seizures (or sometimes called partial seizures), and your seizures are not well controlled with your current treatment. Seizures are caused by abnormal electrical disturbances in the brain. Focalonset seizures occur when this electrical activity remains in a limited area of the brain. The seizures can sometimes turn into generalized seizures, which affect the whole brain. This is called secondary generalization.

Detailed description of study

The name of the study is ARISE (EP0091). This is a Phase II, multicenter, multinational, randomized, double-blind, placebo-controlled, five-arm dose-finding study to evaluate the efficacy and safety of padsevonil (the study drug) as an add-on treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy (i.e., in adults whose seizures are not well controlled with the treatment they are on).

Padsevonil is not yet approved for the treatment of epileptic seizures in epilepsy. The purpose of the current study is to investigate this medication in people with epilepsy. This study aims to test the effectiveness of padsevonil, given in addition to your current epilepsy treatment. The study also aims to see how safe padsevonil is and how well your body can tolerate it. Padsevonil is designed to better control seizures in people who are resistant to other therapies.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: seizures,epilepsy
Age: 18 years - 90 years
Gender: All

Updated on 19 Feb 2024. Study ID: 829787

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