Eligibility

Eligible Ages

Between 12 Years and 75 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

Participants are eligible to be included in the main study only if all of the following
criteria apply:

1. Participant has a documented diagnosis of focal epilepsy according to the ILAE
Classification of Epilepsy, 2017, characterized by focal seizure types with typical
interictal/ictal EEG findings (eg, history of an EEG with focal sharp waves or
slowing). Participants with a documented diagnosis of focal epilepsy and a normal
EEG are eligible for inclusion.

2. Participant is currently treated with at least 1, but no more than 4, antiseizure
medications on a stable regimen.

3. Participant is aged 12 to 75 years old, inclusive, at Screening.

Participants are excluded from the study if any of the following criteria apply:

1. Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can
confound the assessment of the efficacy measures, in the opinion of the
investigator.

2. Has clinically significant unstable medical condition(s), other than epilepsy.

3. History of suicidal behavior, current suicidal risk as determined from history, or
presence of active suicidal ideation as indicated by a positive response to Item 4
or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on
the clinical judgement of the investigator following interview with the participant
and/or caregiver.

4. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of
the study intervention, such as sesame oil.

5. Is currently treated with Epidiolex or received treatment with Epidiolex within 28
days prior to Screening (Visit 1).

6. Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD
based medications, products, or supplements (botanical or synthetic) within 28 days
prior to Screening (Visit 1) and/or is unwilling to abstain for the duration of the
study.

7. Presence of only nonmotor focal aware seizures or primary generalized epilepsies.