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

Jazz Pharmaceuticals · with Jazz Pharmaceuticals Research UK Ltd. · NCT07233239

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
100
US sites recruiting
22
Study start
November 26, 2025
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: CBD-OS

Conditions: Focal Seizures

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Clinical Trial Disclosure & Transparency · 215-832-3750 · ClinicalTrialDisclosure@JazzPharma.com
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A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral… (NCT07233239) | Bored Studies