Cannabidiol oral solution for treating focal-onset seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study gives CBD-OS as an add-on to 1–4 stable antiseizure medications in participants aged 12–75 with focal-onset seizures and compares seizure frequency to each participant's baseline. The trial will collect safety data and pharmacokinetics while measuring changes in seizure frequency and other health outcome endpoints. A substudy will use fMRI and neuropsychological testing to explore potential predictors or mediators of treatment response. Participants will attend regular clinic visits at participating US sites for dosing, monitoring, and outcome assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner University Medical Center-Phoenix
  Phoenix, Arizona, United States Recruiting
• UC San Diego
  La Jolla, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Savannah Neurology Specialists
  Savannah, Georgia, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.