Cannabidiol for Partial Seizures

Not yet recruiting at 22 trial locations

Overseen By Clinical Trial Disclosure & Transparency

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Jazz Pharmaceuticals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 to 75 with focal epilepsy, characterized by specific seizure types and EEG patterns. They must be on a stable regimen of 1-4 antiseizure medications. Those using cannabis products or unwilling to abstain, with only nonmotor seizures, primary generalized epilepsies, significant medical conditions other than epilepsy, suicidal behavior or ideation, hypersensitivity to cannabinoids or sesame oil are excluded.

Inclusion Criteria

I have no history of suicidal behavior or current thoughts of harming myself.

I am allergic to cannabinoids or sesame oil.

I have been diagnosed with focal epilepsy.

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol Oral Solution (CBD-OS)

Trial Overview The study tests Cannabidiol oral solution (CBD-OS) in participants with focal-onset seizures (FOS). It aims to evaluate the efficacy and safety of CBD-OS which is already approved for certain seizure disorders in patients over one year old.

How Is the Trial Designed?

Group I: CBD-OS Experimental Treatment 1 Intervention

Participants who will receive open-label CBD-OS.

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Jazz Pharmaceuticals Research UK Ltd.

Collaborator