NCT07233239 A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
| NCT ID | NCT07233239 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jazz Pharmaceuticals |
| Condition | Focal Seizures |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2027-11-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-11-26 with a primary completion date of 2027-11-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07233239 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 75 Years, studying Focal Seizures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07233239 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07233239 currently recruiting?
Yes, NCT07233239 is actively recruiting participants. Contact the research team at ClinicalTrialDisclosure@JazzPharma.com for enrollment information.
Where is the NCT07233239 trial being conducted?
This trial is being conducted at Phoenix, United States, La Jolla, United States, New Haven, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT07233239 clinical trial?
NCT07233239 is sponsored by Jazz Pharmaceuticals. The trial plans to enroll 100 participants.