Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE2)
- Conditions
- Focal Onset SeizuresMedDRA version: 21.1Level: LLTClassification code: 10065337Term: Focal epilepsy Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-502000-73-00
- Lead Sponsor
- Xenon Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 360
Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study., Subject has a diagnosis (=2 years) of focal epilepsy according to the International League Against Epilepsy 2017 classification criteria. 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., Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP., Subject is able to keep accurate seizure diaries.
Subject has previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures., Subject has history of focal aware non-motor seizures only, Subject has a history of non-epileptic psychogenic seizures., Subject has history of a primary generalized seizure., Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome., Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease., Subject has history of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted., Subject has 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method