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

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in adult subjects diagnosed with FOSs who are taking 1 to 3 ASMs. Eligible subjects will be randomized 1:1:1 (XEN1101 25 mg: 15 mg: placebo) and stratified according to use of background CYP 3A4-inducer ASMs.

Clinical Study Identifier: s22-01190

ClinicalTrials.gov Identifier: NCT05614063

Principal Investigator: Claude Steriade.

Other Investigators: Jacqueline A French, Christopher Elder, Mariana Figuera Losada, Daniel Friedman, Angela M. Curcio.

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