A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures

Inclusion Criteria12

• Participants are eligible to be included in the main study only if all of the following criteria apply:
• 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, focal sharp waves or slowing).
• Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
• Participant is aged 12 to 75 years old, inclusive, at Screening.
• Participants are excluded from the study if any of the following criteria apply:
• 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.
• Has clinically significant unstable medical condition(s), other than epilepsy.
• 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.
• Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.
• Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).
• 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.
• Presence of only nonmotor onset seizures or primary generalized epilepsies.