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Cannabinoid

Cannabidiol for Chronic Liver Injury Prevention

Phase 4
Recruiting
Research Sponsored by GW Research Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is either on existing Epidiolex therapy for treatment of a seizure disorder or is to be started on Epidiolex for treatment of an Food and Drug Administration (FDA)-approved indication.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 365, day 730, day 1095, day 1460, and day 1825
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking or will start taking Epidiolex for seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 365, day 730, day 1095, day 1460, and day 1825
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 365, day 730, day 1095, day 1460, and day 1825 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Liver Fibrosis and Evaluable Fibrotic Changes as Determined and Assessed by an Independent Adjudication Committee
Secondary outcome measures
Change From Baseline in Aspartate Aminotransferase (AST) to Platelet Ratio Index
Change From Baseline in FibroScan Scoring (FibroScan subset only)
Change From Baseline in Fibrosis-4
+5 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Nausea
7%
Diarrhea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control Group

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
34 Previous Clinical Trials
3,058 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,209 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05044819 — Phase 4
Dravet Syndrome Research Study Groups: Cannabidiol
Dravet Syndrome Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05044819 — Phase 4
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05044819 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any possible adverse effects to the application of Cannabidiol for therapeutic purposes?

"Backed by a Phase 4 trial, cannabidiol's safety is confidently assessed as 3 on our 1 to 3 scale."

Answered by AI

What is the highest possible level of participation for this trial?

"Affirmative. As reported on clinicaltrials.gov, this research is still open for recruitment and began July 7th 2021. It has since been updated November 11th 2022, with a total of 150 participants to be enrolled at 29 distinct sites."

Answered by AI

Are there any opportunities for enrolment into this trial currently available?

"Affirmative. Clinicaltrials.gov reveals that recruitment for this research project, first posted on July 7th 2021, is currently underway. 150 participants are being accepted from 29 different sites."

Answered by AI

How widely dispersed are the experiments associated with this investigation throughout the state?

"This study is conducted across 29 different locations, including Wilmington, Richmond and Downey. To reduce travel burdens for participants, it's important to select the facility nearest you."

Answered by AI

Are there any prior investigations of Cannabidiol's therapeutic potential?

"Currently, 79 trials exploring the efficacy of Cannabidiol are in progress. Of these studies, 16 have reached Phase 3 and there is a total of 290 sites across the globe recruiting patients to participate. The majority of clinical locations for this therapeutic agent are located in Ribeirao Preto, Sao Paulo."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
Florida
Texas
What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Trial Site: < 48 hours
Average response time
  • < 2 Days
~83 spots leftby Aug 2027