Focal-Onset Seizures
Conditions
Interventions
Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up
Sponsors
Mick Ribeiro
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of subjects experiencing >=50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo. - MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo. - Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C). | — |
Countries
Austria, Belgium, Croatia, Czechia, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Portugal, Spain, United States
Contacts
Public ContactYusuke Yamakawa
CMIC Co., Ltd.
Outcome results
None listed