Cannabidiol for Chronic Liver Injury Prevention
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not use recreational or medicinal cannabis, or synthetic cannabinoid-based medications other than Epidiolex. Any non-drug therapies, like a ketogenic diet, should be stable before and during the study.
What evidence supports the effectiveness of the drug Cannabidiol (CBD) for preventing chronic liver injury?
Research suggests that CBD may help protect the liver by reducing inflammation and oxidative stress, which are harmful processes that can damage liver cells. Studies in mice have shown that CBD can prevent liver damage caused by alcohol and high-fat diets, indicating its potential to help with liver health.12345
Is cannabidiol (CBD) safe for human liver health?
Research shows that CBD can cause liver enzyme elevations in some people, which may indicate liver stress or injury. In healthy adults, some studies found no significant liver issues, while others reported potential liver injury at high doses. People with liver problems may need lower doses and should be cautious.12356
How does the drug Cannabidiol (CBD) differ from other treatments for chronic liver injury prevention?
Cannabidiol (CBD) is unique because it is a non-psychoactive component of marijuana that helps prevent liver damage by reducing inflammation and oxidative stress, specifically by inhibiting the NFκB-NLRP3 inflammasome-pyroptosis pathway. Unlike other treatments, CBD has shown potential in managing liver conditions related to alcohol and high-fat diets, and it is being explored for its ability to alleviate liver fibrosis and steatosis.12457
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cannabidiol oral solution starting at 5 mg/kg/day for 1 week, then increasing to 10 mg/kg/day
Monitoring
Participants are monitored for potential chronic liver injury and liver fibrosis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cannabidiol
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
GW Research Ltd
Lead Sponsor
Jazz Pharmaceuticals
Lead Sponsor
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