RECRUITINGPhase 3INTERVENTIONAL
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Be properly informed of the nature and risks of the study and give willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
XEN1101
XEN1101 Capsules
DRUG
Placebo
Placebo Capsules
Locations (20)
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Rancho Research Institute
Downey, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
University of California Irvine Health
Orange, California, United States
Panhandle Research and Medical Clinic
Gulf Breeze, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
9D University Health Center
Detroit, Michigan, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Five Towns Neuroscience Research
Woodmere, New York, United States
Duke University Clinic
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Epilepsy Care Center
Austin, Texas, United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States
Hospital Ramos Mejia
Buenos Aires, Argentina
Hospital De Alta Complejidad en Red el Cruce
Buenos Aires, Argentina