RECRUITING

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

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Conditions

Focal Onset SeizuresEpilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05716100

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
  2. * 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.
  3. * 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
  4. * Able to keep accurate seizure diaries
  1. * Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
  2. * History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
  3. * 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.
  4. * History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
  5. * History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
  6. * 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.

Contacts and Locations

Study Contact

Xenon Medical Affairs
CONTACT
1-604-484-3300
XenonCares@xenon-pharma.com

Principal Investigator

Xenon Medical Director
STUDY_DIRECTOR
Xenon Pharmaceuticals Inc.

Study Locations (Sites)

University of California Irvine Health
Orange, California, 92868
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
United States
9D University Health Center
Detroit, Michigan, 48201
United States
Five Towns Neuroscience Research
Woodmere, New York, 11598
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OhioHealth
Columbus, Ohio, 43214
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Xenon Pharmaceuticals Inc.

  • Xenon Medical Director, STUDY_DIRECTOR, Xenon Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-05-09
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Epilepsy

Additional Relevant MeSH Terms

  • Focal Onset Seizures