ClinicalTrials.gg
RecruitingNCT07233239Updated Oct 29, 2026

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

A Phase 1 interventional study of CBD-OS in Focal Seizures, sponsored by Jazz Pharmaceuticals. Recruiting at 24 sites in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Updated Oct 29, 2026Site recruiting status changed2 sites added+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
12 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

This study will assess the efficacy of CBD-OS as an adjunctive treatment in reducing the frequency of focal seizures compared to baseline as well as the effect of CBD-OS on health outcome endpoints in early line and refractory participants with FOS. This study will also examine pharmacokinetics (PK), safety, and potential predictors or mediators of treatment response, including functional magnetic resonance imaging (fMRI) and neuropsychological testing in a substudy.

02

Conditions studied

  • Focal Seizures

Browse trials for

Keywords

  • Focal Seizures
03

In context

Seizures

766 studies on the registry are indexed under Seizures; 136 are open to participants now.

This study's planned enrollment of 100 is above the median of 64 across 519 interventional studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 173 studies on the registry; 18 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 32 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 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 to cannabinoids or any of the 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CBD-OS

    Participants who will receive open-label CBD-OS.

    Drug: CBD-OS

Interventions

  • DrugCBD-OS

    Starting dose of CBD-OS will be administered as per the approved local product label

    Also known as: GWP42003-P, JZP926

06

What researchers measure

Primary outcomes

  1. Percent change in countable focal seizure frequency compared to baseline

    Time frame: Baseline up to 16 weeks

07

Study locations

21 of 24 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

3 registry updates since Sep 25, 2026
Sites
2 sites added, 2 sites removed. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Hackensack Meridian Neuroscience Institute at JFK University Medical Center · Edison, United StatesNot yet recruiting→Recruiting
  • Banner University Medical Center-Phoenix · Phoenix, United StatesNot yet recruiting→Recruiting
Show 2 added (2 United States)
  • Serenity Research Center, LLC · Miami, United States
  • Thomas Jefferson University · Philadelphia, United States
Show 2 removed
  • Onsite Clinical Solutions · Charlotte, United States
  • William S Middleton Memorial Veterans Hospital · Madison, United States
across 3 updates, Oct 2, 2026 – Oct 29, 2026
Show all 3 updates
  1. Oct 29, 2026
    2 sites added, 2 sites removed
    Show 2 added (2 United States)
    • Serenity Research Center, LLC · Miami, United States
    • Thomas Jefferson University · Philadelphia, United States
    Show 2 removed
    • Onsite Clinical Solutions · Charlotte, United States
    • William S Middleton Memorial Veterans Hospital · Madison, United States
  2. Oct 26, 2026
    Banner University Medical Center-Phoenix is now Recruiting
    + 1 other change: verification date
  3. Oct 2, 2026
    Hackensack Meridian Neuroscience Institute at JFK University Medical Center is now Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07233239
Collaborators
Jazz Pharmaceuticals Research UK Ltd.
Responsible party
Sponsor
First posted
Nov 18, 2025
Start date
Nov 26, 2025
Primary completion
Nov 29, 2027 (estimated)
Completion
Nov 29, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Clinical Trial Disclosure & Transparency
Contact
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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