Xenon
A 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 (Xenon)
Purpose
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
adults diagnosed with focal epilepsy and taking 1 to 3 anti-seizure medications (ASMs).
Who can participate
- Adults 18 years and older
- Diagnosis (≥2 years) of focal epilepsy
- Stable dose of 1 to 3 allowable current ASMs for at least 1 month
- If implanted vagal nerve stimulator, deep brain stimulation, or responsive neurostimulator system, the stimulator, stimulation, or neurostimulator system must be present for >1 year prior to entry into the DBP, and the battery does not need to be replaced during the study
Visits
Total study duration is approximately 29.5 weeks (up to approximately 7 months). Patients who complete the study may be eligible for and the open label extension study which is being conducted under a separate protocol (XPF-010-304).
