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 (NCT05716100)

The main purpose of this study is to determine if XEN1101 can reduce seizure frequency in people with focal epilepsy and if it is safe to use. In this study 360 participants globally will be randomly assigned to receive either XEN1101 (25mg/day or 15mg/day) or placebo (an inactive substance) for 12 weeks, in addition to their usual anti-seizure medications.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof Terence O'Brien

Key inclusion data

?18 years of age with a BMI ?40 kg/m2 at Visit 1. Subject has a diagnosis (?2 years) of focal epilepsy according to the International League Against Epilepsy 2017 classification criteria. Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom. Subject has prior neuroimaging (CT or MRI) within the last 10 years (performed after the onset of seizures) and documentation is available. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP.