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Cannabinoid
Cannabidiol for Chronic Liver Injury Prevention
Phase 4
Waitlist Available
Research Sponsored by GW Research Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will look for possible long-term liver damage and scarring in people taking cannabidiol by mouth.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, common side effects of cannabidiol may include tiredness, diarrhea, changes in appetite/weight. Since this trial focuses on potential chronic liver injury from Epidiolex use over time; monitoring will be specifically looking at signs of such damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CannabidiolExperimental Treatment1 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
GW Research LtdLead Sponsor
35 Previous Clinical Trials
3,071 Total Patients Enrolled
5 Trials studying Lennox Gastaut Syndrome
1,104 Patients Enrolled for Lennox Gastaut Syndrome
Jazz Pharmaceuticals Research UK LimitedIndustry Sponsor
Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,690 Total Patients Enrolled
6 Trials studying Lennox Gastaut Syndrome
1,174 Patients Enrolled for Lennox Gastaut Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable non-drug therapy, like a special diet, for at least 4 weeks.I plan to undergo epilepsy or major surgery within the next five years.My liver function tests are significantly above normal levels.I am currently taking or will start taking Epidiolex for seizures.I have used cannabis or synthetic cannabinoid-based medications recently.I am not pregnant, breastfeeding, or planning to become pregnant during the study and for 3 months after.My liver is scarred, with a FibroScan score of 6.5 or higher.I am within the age range approved for this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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