Skip to content

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 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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07233239
Enrollment
100
Registered
2025-11-18
Start date
2025-11-26
Completion date
2027-11-29
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Seizures

Keywords

Focal Seizures

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).

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

DRUGCBD-OS

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

Sponsors

Jazz Pharmaceuticals
Lead SponsorINDUSTRY
Jazz Pharmaceuticals Research UK Ltd.
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Percent change in countable focal seizure frequency compared to baselineBaseline up to 16 weeks

Countries

United States

Contacts

CONTACTClinical Trial Disclosure & Transparency
ClinicalTrialDisclosure@JazzPharma.com215-832-3750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026