Randomized Double-blind Placebo-Controlled Multicenter Phase 3 Study to Evaluate the Safety Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

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Randomized Double-blind Placebo-Controlled Multicenter Phase 3 Study to Evaluate the Safety Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

Brief description of study

In this research a study drug named XEN1101 is being tested for the treatment of seizures. XEN1101 is a study drug because its safety, effectiveness, and/or how it works is/are still being studied. XEN1101 has not been approved for commercial use by government health authorities in any country, as a treatment for any condition.

The main purpose of this study is to determine if XEN1101 can reduce the seizure frequency and if it is safe to use. XEN1101 has been tested in other studies in epilepsy patients and it was considered to be well-tolerated. It had side effects that are similar to other antiseizure drugs commonly used to help patients with epilepsy.

The study will compare XEN1101 to a placebo to see if XEN1101 is safe and works better than the placebo.

Clinical Study Identifier: s22-01190

ClinicalTrials.gov Identifier: NCT05614063

Principal Investigator: Claude Steriade.

Other Investigators: Mariana Figuera Losada, Jacqueline A French, Daniel Friedman.

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