Back to search results

X-TOLE3 Study: XEN1101 for Focal-Onset Seizures

This study, called X-TOLE3, is testing a medication called XEN1101 against a placebo (an inactive pill) to see if it can reduce the frequency of focal-onset seizures. You may be able to join if you are 18 or older, have been diagnosed with focal epilepsy for at least two years, and are currently taking 1 to 3 stable anti-seizure medications. The main goal is to see how much the number of seizures changes for people taking XEN1101 compared to those taking the placebo over 12 weeks. The study aims to enroll about 360 participants, but its current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive XEN1101 or placebo, and neither you nor your doctor will know which you are receiving. About 360 people will participate.
What's involved
You will have up to 9.5 weeks to track your seizure frequency, followed by 12 weeks of taking XEN1101 or placebo once daily with an evening meal. You must be on 1 to 3 stable anti-seizure medications throughout the study.
Compensation
Not stated in the trial record.
Follow-up
If you complete the 12-week treatment period and do not join a separate extension study, you will have an 8-week follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05716100

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Xenon Pharmaceuticals Inc.
~360 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:XEN1101Placebo

At a glance

Recruiting sites
59 of 95 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Measured over From baseline through to the double blind period (week 12).

Conditions

Focal Onset Seizures

Explore related trials

Partial Seizure

Where it's being run

95 sites across 36 states
Argentina12
Portugal8
France6
Croatia5
Poland5
Chile4
Israel4
Mexico4

Study leadership

  • Xenon Medical Director · STUDY_DIRECTOR · Xenon Pharmaceuticals Inc.

Who to contact

Xenon Medical Affairs
[email protected]
1-604-484-3300
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). 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.
Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
Able to keep accurate seizure diaries

Exclusion

Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

What this trial measures

  • Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.From baseline through to the double blind period (week 12).