A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE2)
Focal Onset Seizures
About this trial
This is an interventional treatment trial for Focal Onset Seizures focused on measuring Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Clinical Trials, IncRecruiting
- Brain Science Research InstituteRecruiting
- CPMC Research InstituteRecruiting
- Research Institute of Orlando, LLCRecruiting
- Panhandle Research & Medical ClinicRecruiting
- Georgia Neurology and Sleep Medicine AssociatesRecruiting
- Hawaii Pacific NeuroscienceRecruiting
- Bluegrass Epilepsy Research, LLCRecruiting
- UK HealthCare - Kentucky Neuroscience Institute (KNI)Recruiting
- MMP NeurologyRecruiting
- Mid-Atlantic Epilepsy and Sleep CenterRecruiting
- University of MichiganRecruiting
- Michigan State UniversityRecruiting
- Minneapolis Clinic of NeurologyRecruiting
- Northeast Epilepsy GroupRecruiting
- Montefiore Medical CenterRecruiting
- Dent Neurosciences Research CenterRecruiting
- SUNY Upstate Medical UniversityRecruiting
- Meridian Clinical ResearchRecruiting
- Providence Brain & Spine InstituteRecruiting
- Thomas Jefferson UniversityRecruiting
- Austin Epilepsy Care Center (AECC)Recruiting
- Carilion Clinic - NeurologyRecruiting
- University of Washington Main HospitalRecruiting
- The University of Queensland (UQ)Recruiting
- Southern NeurologyRecruiting
- Alfred HealthRecruiting
- The Royal Melbourne HospitalRecruiting
- Center For Neurologic ResearchRecruiting
- Hospital Clinico San CarlosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
XEN1101 25 mg/day
XEN1101 15 mg/day
Placebo
XEN1101 25 mg/day
XEN1101 15 mg/day
Placebo