Evaluating XEN1101 for Focal-Onset Seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of XEN1101 as an adjunctive therapy for patients with focal-onset seizures. Approximately 360 participants will be randomly assigned to receive either XEN1101 at two different dosages or a placebo over a 12-week treatment period. Eligible participants must have a diagnosis of focal epilepsy and have been on stable doses of antiseizure medications prior to the study. The trial includes a baseline period to monitor seizure frequency and allows for an open-label extension for those who complete the initial treatment phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• University of California Los Angeles (UCLA)
  Los Angeles, California, United States Recruiting
• University of California Irvine Health
  Orange, California, United States Recruiting
• Panhandle Research and Medical Clinic
  Gulf Breeze, Florida, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Consultants in Epilepsy and Neurology, PLLC
  Boise, Idaho, United States Recruiting
• Southern Illinois University School of Medicine
  Springfield, Illinois, United States Recruiting

+53 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Xenon Medical Affairs
• Email: XenonCares@xenon-pharma.com
• Phone: 1-604-484-3300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Eslicarbazepine in adults with focal-onset seizures

  This project tests how eslicarbazepine works in adults with focal-onset seizures in routine care, including those who are new to treatment and those switching from carbamazepine or oxcarbazepine.

  Recruiting King Edward Medical University · Lahore, Punjab Province · NCT07793396

• Evaluating SPN-817 for adults with focal onset seizures

  This study is testing a new medication called SPN-817 to see if it can help adults with focal onset seizures who haven't found relief from other treatments.

  Recruiting at 60 sites Phase 2 Supernus Pharmaceuticals, Inc. · Phoenix, Arizona and 62 other locations · NCT06798896

• Evaluating XEN1101 for treating primary generalized tonic-clonic seizures

  This study is testing a new medication called XEN1101 to see if it can help people aged 12 and older with primary generalized tonic-clonic seizures who are still having seizures despite taking other medications.

  Recruiting at 99 sites Phase 3 Xenon Pharmaceuticals Inc. · Mobile, Alabama and 140 other locations · NCT05667142

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.