Cannabidiol for Chronic Liver Injury Prevention

Recruiting at 27 trial locations

Overseen By Medical Enquiries

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: GW Research Ltd

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

Eligibility Criteria

This trial is for individuals with Lennox Gastaut Syndrome, Dravet Syndrome, or Tuberous Sclerosis who are already taking or starting Epidiolex (cannabidiol) therapy. They must avoid heavy exercise before visits and maintain stable non-drug therapies. Exclusions include recent cannabis use, planned major surgery within five years, pregnancy, significant health risks as determined by the investigator, participation in other drug trials within three months prior to screening, certain liver conditions or diseases that cause liver fibrosis.

Inclusion Criteria

I have been on a stable non-drug therapy, like a special diet, for at least 4 weeks.

I am currently taking or will start taking Epidiolex for seizures.

Participant is willing to refrain from strenuous exercise 48 to 72 hours prior to all study visits with the exception of unscheduled visits.

Exclusion Criteria

Participation in any clinical trial involving an investigational medicinal product within 3 months prior to the Screening Visit or at any point during this study.

Following a physical examination, if the participant has any abnormalities that, in the opinion of the investigator, would prevent the participant from safe participation in the study.

I plan to undergo epilepsy or major surgery within the next five years.

Treatment Details

Interventions

• Cannabidiol (Cannabinoid)

Trial Overview The study is monitoring participants treated with cannabidiol oral solution for chronic liver injury and liver fibrosis. Cannabidiol is being tested for its long-term safety on the liver among those using it to manage seizures related to specific syndromes.

Participant Groups

Group I: Cannabidiol Experimental Treatment 1 Intervention

Cannabidiol solution 100 milligrams per milliliter (mg/mL) will be administered orally at a dose level of 5 mg/kg/day for 1 week, then increase to 10 mg/kg/day by the participant or their caregiver twice each day (morning and evening).

Cannabidiol is already approved in Canada for the following indications:

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

GW Research Ltd

Lead Sponsor

Trials

36

Recruited

3,200+

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 Limited

Industry Sponsor

Trials

1

Recruited

150+