Padsevonil as adjunctive treatment of focal-onset seizures
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
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Age: Between 18 Years - 90 Years
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Gender: All
Updated on
29 May 2023.
Study ID: 829787