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Recruiting NCT07233239

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

Phase I Interventional Focal Seizures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBD-OS.
Who it may be relevant to
Registry conditions: Focal Seizures. Basic parameters: 12 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 24 centers
  • Banner University Medical Center-Phoenix — Phoenix
  • UC San Diego — La Jolla
  • Yale University — New Haven
  • University of South Florida — Tampa
  • Emory University — Atlanta
  • Savannah Neurology Specialists — Savannah
  • Northwestern University — Chicago
  • Mid-Atlantic Epilepsy and Sleep Center — Bethesda
  • … and 16 more centers

Identifiers

NCT: NCT07233239 · JZP926-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗