Home › Trials › NCT07233239

Cannabidiol oral solution for treating focal-onset seizures

A Phase 1b, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) in Participants Aged 12 to 75 Years for the Treatment of Focal-Onset Seizures

Phase 1 Interventional Jazz Pharmaceuticals · NCT07233239

We will test whether a cannabidiol oral solution (CBD-OS) can reduce focal-onset seizures in people aged 12 to 75 who are taking 1–4 stable antiseizure medications.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment100 (estimated)
Ages12 Years to 75 Years
SexAll
SponsorJazz Pharmaceuticals Industry-sponsored
Locations24 sites (Phoenix, Arizona and 23 other locations)
Trial IDNCT07233239 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People aged 12–75 with a documented diagnosis of focal epilepsy who are on a stable regimen of 1–4 antiseizure medications are the intended participants for this study.

Not a fit: People with confirmed non-epileptic events, clinically unstable medical conditions, or those outside the age or medication criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, CBD-OS could provide an additional treatment option to lower seizure frequency and improve quality of life for people with focal-onset seizures.

How similar studies have performed: Cannabidiol is already effective and approved for seizures in Lennox-Gastaut, Dravet, and TSC, but its effectiveness specifically for focal-onset seizures is less well established.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Focal Seizures
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.