Recruiting
Phase 1

Cannabidiol Oral Solution

Sponsor:

Jazz Pharmaceuticals

Code:

NCT07233239

Conditions

Focal Seizures

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

CBD-OS

Study Details

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).

Conditions

Focal Seizures

Study ID

NCT07233239

Start date

Nov 26, 2025

Status verified date

Aug, 2026

Completion date

Nov 29, 2027

Anticipated

Primary completion date

Nov 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBD-OS

Participants who will receive open-label CBD-OS.

Interventions

CBD-OS

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

Primary outcome measure

  • Percent change in countable focal seizure frequency compared to baseline [ Time Frame: Baseline up to 16 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure & Transparency

215-832-3750ClinicalTrialDisclosure@JazzPharma.com

Locations

UC San Diego

Recruiting

La Jolla, California, United States, 92037-1300

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Savannah Neurology Specialists

Recruiting

Savannah, Georgia, United States, 31406

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Mid-Atlantic Epilepsy and Sleep Center

Recruiting

Bethesda, Maryland, United States, 20817

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Saint Peter's University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Boston Children's Health Physicians

Recruiting

Hawthorne, New York, United States, 10532

Onsite Clinical Solutions

Recruiting

Charlotte, North Carolina, United States, 28211

Velocity Clinical Research at Raleigh Neurology

Recruiting

Raleigh, North Carolina, United States, 27607

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

University of Cincinnati, Gardner Neuroscience Institute

Recruiting

Cincinnati, Ohio, United States, 45267-0525

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Child Neurology & Consultants of Austin

Recruiting

Austin, Texas, United States, 78757

ANESC Research

Recruiting

El Paso, Texas, United States, 79912

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Focal Seizures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2026-08-11.