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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT07233239
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Focal Seizures

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Nov 26, 2025
Status verified
Jun 2026
Primary completion
Nov 29, 2027
Completion
Nov 29, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CBD-OS
    Participants who will receive open-label CBD-OS.

Primary Outcome Measure

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

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Banner University Medical Center-PhoenixPhoenixArizona85006-
UC San DiegoLa JollaCalifornia92037-1300-
Yale UniversityNew HavenConnecticut06510-
University of South FloridaTampaFlorida33606-
Emory UniversityAtlantaGeorgia30329-
Savannah Neurology SpecialistsSavannahGeorgia31406-
Northwestern UniversityChicagoIllinois60611-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-
Wayne State UniversityDetroitMichigan48201-
Corewell HealthGrand RapidsMichigan49503-
Hackensack Meridian Neuroscience Institute at JFK University Medical CenterEdisonNew Jersey08820-
Saint Peter's University HospitalNew BrunswickNew Jersey08901-
Boston Children's Health PhysiciansHawthorneNew York10532-
Onsite Clinical SolutionsCharlotteNorth Carolina28211-
Velocity Clinical Research at Raleigh NeurologyRaleighNorth Carolina27607-
Cincinnati Children's HospitalCincinnatiOhio45229-
University of Cincinnati, Gardner Neuroscience InstituteCincinnatiOhio45267-0525-
Oregon Health & Science UniversityPortlandOregon97239-
Le Bonheur Children's HospitalMemphisTennessee38103-
Child Neurology & Consultants of AustinAustinTexas78757-
ANESC ResearchEl PasoTexas79912-
Intermountain HealthMurrayUtah84107-
Seattle Children's HospitalSeattleWashington98105-
William S Middleton Memorial Veterans HospitalMadisonWisconsin53705-

Find similar trials in Phoenix, AZ

By research site
Banner University Medical Center-Phoenix· Phoenix, AZUC San Diego· La Jolla, CAYale University· New Haven, CTUniversity of South Florida· Tampa, FLEmory University· Atlanta, GASavannah Neurology Specialists· Savannah, GA