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

Description

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Conditions

Focal Onset Seizures

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Study Overview

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Study Details

Study overview

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

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

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

Condition
Focal Onset Seizures
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine Health, Orange, California, United States, 92868

Springfield

Southern Illinois University School of Medicine, Springfield, Illinois, United States, 62794

Detroit

9D University Health Center, Detroit, Michigan, United States, 48201

Woodmere

Five Towns Neuroscience Research, Woodmere, New York, United States, 11598

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Columbus

OhioHealth, Columbus, Ohio, United States, 43214

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Salt Lake City

University of Utah Clinical Neurosciences Center, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Xenon Pharmaceuticals Inc.,

Xenon Medical Director, STUDY_DIRECTOR, Xenon Pharmaceuticals Inc.

Study Record Dates

2025-12