Focal SeizuresPhase 1NCT07233239
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 study testing CBD-OS in people with Focal Seizures, run by Jazz Pharmaceuticals at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Focal Seizures
- What is being tested?
- CBD-OS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 24 sitesUnited States
- Study dates
- 26 Nov 2025to 29 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Participants are eligible to be included in the main study only if all of the following criteria apply:
- 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.
Participants are excluded from the study if any of the following criteria apply:
- 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.
- Has clinically significant unstable medical condition(s), other than epilepsy.
- 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.
- Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.
- Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).
- 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.
- Presence of only nonmotor focal aware seizures or primary generalized epilepsies.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
United States24 sites, 24 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30329
- Recruiting
Child Neurology & Consultants of Austin
Austin, Texas, 78757
- Recruiting
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Recruiting
University of Cincinnati, Gardner Neuroscience Institute
Cincinnati, Ohio, 45267-0525
- Recruiting
Wayne State University
Detroit, Michigan, 48201
- Recruiting
Hackensack Meridian Neuroscience Institute at JFK University Medical Center
Edison, New Jersey, 08820
- Recruiting
ANESC Research
El Paso, Texas, 79912
- Not yet recruiting
Corewell Health
Grand Rapids, Michigan, 49503
- Recruiting
Boston Children's Health Physicians
Hawthorne, New York, 10532
- Recruiting
UC San Diego
La Jolla, California, 92037-1300
- Recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
- Not yet recruiting
Serenity Research Center, LLC
Miami, Florida, 33176
- Recruiting
Intermountain Health
Murray, Utah, 84107
- Recruiting
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
- Recruiting
Yale University
New Haven, Connecticut, 06510
- Not yet recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Banner University Medical Center-Phoenix
Phoenix, Arizona, 85006
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, 27607
- Recruiting
Savannah Neurology Specialists
Savannah, Georgia, 31406
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
- Recruiting
University of South Florida
Tampa, Florida, 33606
About this study
Official title: 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
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.
- Conditions
- Focal Seizures
- Being tested
- CBD-OS
- Keywords
- Focal Seizures
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD-OSDrug
Also called GWP42003-P, JZP926
Starting dose of CBD-OS will be administered as per the approved local product label
| Study group | Role | What they receive |
|---|---|---|
| CBD-OS | Experimental | Participants who will receive open-label CBD-OS. Receives: Drug: CBD-OS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in countable focal seizure frequency compared to baseline
Measured: Baseline up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start26 Nov 2025
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal SeizuresStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Research UK Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233239
- Sponsor's protocol ID
- JZP926-105
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07233239
- Acronym / sponsor ID
- JZP926-105
- Conditions
- Focal Seizures
- Keywords
- Focal Seizures
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Research UK Ltd.
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBD-OS | Experimental | Drug: CBD-OSParticipants who will receive open-label CBD-OS. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD-OSAlso: GWP42003-P, JZP926Starting dose of CBD-OS will be administered as per the approved local product label | Drug | CBD-OS |
Primary outcome
Percent change in countable focal seizure frequency compared to baseline
Time frame: Baseline up to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBD-OS in people with Focal Seizures, run by Jazz Pharmaceuticals at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in countable focal seizure frequency compared to baseline (time frame: Baseline up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.