XEN1101 for Epilepsy
(X-TOLE Trial)

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Xenon Pharmaceuticals Inc.

Stay on Your Current Meds

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests XEN1101, a new medication, in adults with focal epilepsy who still have seizures despite taking other anti-epileptic drugs. The goal is to see if XEN1101 can better control their seizures by working with their current medications.

Eligibility Criteria

Adults with a diagnosis of focal epilepsy for at least 2 years, BMI ≤40 kg/m2, on stable doses of 1-3 approved AEDs can join. They must have had prior neuroimaging and be able to keep seizure diaries. Exclusions include history of certain non-focal seizures, recent neurosurgery, psychotic disorders or suicide risk, significant medical conditions like long QT syndrome or cancer within the past two years.

Inclusion Criteria

I agree not to donate sperm/ova during the study and for 6 months after.

Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study

I have been on 1 to 3 epilepsy drugs at a stable dose for at least a month.

See 5 more

Exclusion Criteria

I have had severe allergic reactions to epilepsy drugs.

My seizures are caused by another health condition.

I had neurosurgery for seizures less than a year ago, or radiosurgery less than two years ago.

See 11 more

Treatment Details

Interventions

XEN1101 (Other)

Trial OverviewThe trial is testing XEN1101 as an additional treatment for focal epilepsy in adults. It's a randomized study where patients either get XEN1101 or a placebo without knowing which one they're getting. After that phase, there's an optional part where everyone gets XEN1101.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 25 mg XEN1101Experimental Treatment1 Intervention

Capsule filled with 25 mg XEN1101

Group II: 20 mg XEN1101Experimental Treatment1 Intervention

Capsule filled with 20 mg XEN1101

Group III: 10 mg XEN1101Experimental Treatment1 Intervention

Capsule filled with 10 mg XEN1101

Group IV: PlaceboPlacebo Group1 Intervention

Placebo capsule