A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Description

The X-TOLE2 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

Talk to us

Study Overview

On this page

Study Details

Study overview

The X-TOLE2 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

Condition
Focal Onset Seizures
Intervention / Treatment

-

Contacts and Locations

Mobile

Strada Patient Care Center, Mobile, Alabama, United States, 36604

Phoenix

Xenoscience, Phoenix, Arizona, United States, 85004

Phoenix

St. Joseph's Hospital, Phoenix, Arizona, United States, 85013

Little Rock

Clinical Trials, Inc, Little Rock, Arkansas, United States, 72205

Los Angeles

Brain Science Research Institute, Los Angeles, California, United States, 90025

Sacramento

UC Davis Clinical and Translational Science Center Clinical Research, Sacramento, California, United States, 95817

San Francisco

CPMC Research Institute, San Francisco, California, United States, 94107

Aurora

Anschutz Health Sciences, Aurora, Colorado, United States, 80011

Coral Gables

Floridian Community Research Center, Coral Gables, Florida, United States, 33134

Miami

Serenity Research, Miami, Florida, United States, 33176

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.,

Medical Director, STUDY_DIRECTOR, Xenon Pharmaceuticals Inc.

Study Record Dates

2025-06