Eligibility Details:
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 <35 kg/m2
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against
Epilepsy [ILAE] Classification of Epilepsy (2017)
- 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 study
- Must be willing to comply with the contraception requirements
- 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 <1 year prior to enrollment, or radiosurgery <2
years prior to enrollment
- Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the
past 6 months, or a history of suicide attempt in the last 2 years, or more than 1
lifetime suicide attempt
- History or presence of any significant medical or surgical condition or uncontrolled
medical illness at screening, or history of cancer within the past 2 years, with the
exception of appropriately treated basal cell or squamous cell carcinoma
- Any clinically significant abnormalities on pre-study physical examination, vital
signs, laboratory values or ECG indicating a medical problem that would preclude study
participation
- 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 ≥49 days and acceptable hematology and LFT values (or
discontinued felbamate 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