XEN1101 for Seizures (X-ACKT Trial)

Recruiting in Palo Alto (17 mi)

+129 other locations

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Xenon Pharmaceuticals Inc.

Stay on your current meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests XEN1101, a medication added to current treatments, in people with generalized epilepsy experiencing PGTCS who are already on 1-3 anti-seizure medications. The goal is to see if taking XEN1101 with an evening meal can help reduce seizure frequency.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current anti-seizure medications throughout the study.

Eligibility Criteria

This trial is for adults over 18 with a BMI ≤40 who have generalized epilepsy with tonic-clonic seizures despite trying at least two anti-seizure medications. They must be on a stable dose of their current meds and able to track their seizures. Excluded are those with recent severe seizure episodes, non-epileptic psychogenic seizures, or significant mental health issues.

Participant Groups

The study tests XEN1101 as an additional treatment for epilepsy against a placebo in a double-blind setup, meaning neither the participants nor the researchers know who's getting the real drug versus the placebo during the trial.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: XEN1101 25 mg/dayExperimental Treatment1 Intervention

XEN1101 25 mg/day

Group II: XEN1101 15 mg/dayExperimental Treatment1 Intervention

XEN1101 15 mg/day

Group III: PlaceboPlacebo Group1 Intervention

Placebo