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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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, focal sharp waves or slowing).

• 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 onset seizures or primary generalized epilepsies.

Locations
United States
Arizona
Banner University Medical Center-Phoenix
NOT_YET_RECRUITING
Phoenix
California
UC San Diego
NOT_YET_RECRUITING
La Jolla
Connecticut
Yale University
NOT_YET_RECRUITING
New Haven
Florida
University of South Florida
NOT_YET_RECRUITING
Tampa
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Savannah Neurology Specialists
RECRUITING
Savannah
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Maryland
Mid-Atlantic Epilepsy and Sleep Center
NOT_YET_RECRUITING
Bethesda
Michigan
Wayne State University
NOT_YET_RECRUITING
Detroit
Corewell Health
NOT_YET_RECRUITING
Grand Rapids
North Carolina
Onsite Clinical Solutions
RECRUITING
Charlotte
Velocity Clinical Research at Raleigh Neurology
RECRUITING
Raleigh
New Jersey
Hackensack Meridian Neuroscience Institute at JFK University Medical Center
NOT_YET_RECRUITING
Edison
Saint Peter's University Hospital
RECRUITING
New Brunswick
New York
Boston Children's Health Physicians
NOT_YET_RECRUITING
Hawthorne
Ohio
Cincinnati Children's Hospital
NOT_YET_RECRUITING
Cincinnati
University of Cincinnati, Gardner Neuroscience Institute
NOT_YET_RECRUITING
Cincinnati
Oregon
Oregon Health & Science University
NOT_YET_RECRUITING
Portland
Tennessee
Le Bonheur Children's Hospital
NOT_YET_RECRUITING
Memphis
Texas
Child Neurology & Consultants of Austin
NOT_YET_RECRUITING
Austin
ANESC Research
RECRUITING
El Paso
Washington
Seattle Children's Hospital
NOT_YET_RECRUITING
Seattle
Wisconsin
William S Middleton Memorial Veterans Hospital
NOT_YET_RECRUITING
Madison
Contact Information
Primary
Clinical Trial Disclosure & Transparency
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2027-11-29
Participants
Target number of participants: 100
Treatments
Experimental: CBD-OS
Participants who will receive open-label CBD-OS.
Sponsors
Leads: Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Research UK Ltd.

This content was sourced from clinicaltrials.gov