Padsevonil as adjunctive treatment of focal-onset seizures

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Study Overview

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.

Study Description

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.

Additional Information:

Your participation in this study, ARISE (EP0091), could last up to 27 weeks. The first 4 weeks we will collect some baseline information about you and your seizures. Then you will be given a medication for a maximum of 16 weeks during the treatment period. Then there is a conversion or taper period of 3 to 4 weeks, and a follow-up visit will be performed 30 days after you took the last study medication. During your total participation, you will receive study medication for up to 20 weeks. One additional safety follow-up will be performed at approximately 6 months (±1 month) after the last dose of study medication in case you discontinue the study after you took the study medication for more than 3 weeks.

After approximately 20 weeks in the study (including 16 weeks under treatment), you may have the opportunity to decide to enroll in an open-label extension study, EP0093, in which all participants will receive padsevonil, or to discontinue the study drug. 

  • Study Identifier: 829787

Recruitment Status

Open

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