Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older. This study will assess the efficacy and safety of CBD-OS in participants aged 12 to 75 years for the treatment of focal-onset seizures (FOS).
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.
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.
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.
None
Single group
CBD-OS
DrugStarting dose of CBD-OS will be administered as per the approved local product label
Percent change in countable focal seizure frequency compared to baseline
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Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Research UK Ltd.
Collaborator
