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Cannabidiol for Lennox Gastaut Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Clinical Trial Site, Cincinnati, OHLennox Gastaut Syndrome+2 MoreCannabidiol - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial will look for possible long-term liver damage and scarring in people taking cannabidiol by mouth.

Eligible Conditions
  • Lennox Gastaut Syndrome
  • Dravet Syndrome
  • Tuberous Sclerosis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
Cannabidiol
1
Cannabidiol
1
Cannabidiol

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825

Day 1825
Change From Baseline in Aspartate Aminotransferase (AST) to Platelet Ratio Index
Change From Baseline in FibroScan Scoring
Change From Baseline in Fibrosis-4
Change from Baseline in the Enhanced Liver Fibrosis Score
Day 1825
Number of Participants With Clinically Significant Clinical Laboratory Findings
Number of Participants With Clinically Significant Physical Examinations
Number of Participants With Potential Drug-Induced Liver Injury (DILI)
Number of Participants with Severe Treatment-emergent Adverse Events
Day 1825
Number of Participants With Liver Fibrosis and Evaluable Fibrotic Changes as Determined and Assessed by an Independent Adjudication Committee

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Cannabidiol
1
Cannabidiol
1
Cannabidiol

Side Effects for

CBD Oil Group
38%Tiredness
24%Poor sleep
24%Drowsiness
22%Constipation
18%Poor Appetite
16%Dizziness
9%Headache
7%Diarrhea
7%Nausea
4%Itching
This histogram enumerates side effects from a completed 2022 Phase 2 & 3 trial (NCT04387617) in the CBD Oil Group ARM group. Side effects include: Tiredness with 38%, Poor sleep with 24%, Drowsiness with 24%, Constipation with 22%, Poor Appetite with 18%.

Trial Design

1 Treatment Group

Cannabidiol
1 of 1

Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: Cannabidiol · No Placebo Group · Phase 4

Cannabidiol
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 365, day 730, day 1095, day 1460, and day 1825

Who is running the clinical trial?

GW Research LtdLead Sponsor
34 Previous Clinical Trials
3,092 Total Patients Enrolled
5 Trials studying Lennox Gastaut Syndrome
1,104 Patients Enrolled for Lennox Gastaut Syndrome
Jazz PharmaceuticalsLead Sponsor
224 Previous Clinical Trials
30,766 Total Patients Enrolled
6 Trials studying Lennox Gastaut Syndrome
1,174 Patients Enrolled for Lennox Gastaut Syndrome

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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