XENON · XPF-008-201

Public study eligibility criteria

• Key Inclusion Criteria:
• * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
• * BMI ≤40 kg/m2
• * Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy \[ILAE\] Classification of Epilepsy (2017)
• * Prior neuroimaging within the last 10 years and documentation is available
• * Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
• * Must be willing to comply with the contraception requirements
• * Males must agree not to donate sperm from the time of the first administration of study drug until 6 months after the last dose. Females must agree not to donate ova from the time of the first administration of study drug until 6 months after the last dose.
• * Able to keep accurate seizure diaries
• Key Exclusion Criteria:
• * History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only
• * Presence or previous history of Lennox-Gastaut syndrome
• * Seizures secondary to other diseases or conditions
• * History of repetitive seizures within the last 12 months where the individual seizures cannot be counted
• * History of neurosurgery for seizures \ 450 msec at baseline; family history of sudden death of unknown cause
• 2. History of skin or retinal pigment epithelium abnormalities caused by ezogabine
• * Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)
• * If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for 2 months (or no less than 49 days) and acceptable hematology and LFT history and values prior to Screening. If received in the past, felbamate must have been discontinued 2 months (or no less than 49 days) prior to Screening.
• * Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
• * Current use of a ketogenic diet