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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR EPIDIOLEX


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505(b)(2) Clinical Trials for Epidiolex

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed Benign Essential Blepharospasm Research Foundation Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed GW Pharmaceuticals Ltd. Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed Smith-Kettlewell Eye Research Institute Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed Silkiss Eye Surgery Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Epidiolex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02006628 ↗ A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder Completed GW Research Ltd Phase 2 2014-02-25 A study to compare the change in symptom severity in participants with schizophrenia or related psychotic disorder when treated with GWP42003 or placebo in conjunction with existing anti-psychotic therapy over a period of six weeks.
NCT02091206 ↗ A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1) Completed GW Research Ltd Phase 2 2014-10-22 To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.
NCT02091375 ↗ Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1) Completed GW Research Ltd Phase 3 2015-03-30 To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
NCT02224560 ↗ Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults Completed GW Research Ltd Phase 3 2015-06-08 The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Epidiolex

Condition Name

Condition Name for Epidiolex
Intervention Trials
Epilepsy 14
Dravet Syndrome 5
Lennox-Gastaut Syndrome 4
CBD 3
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Condition MeSH

Condition MeSH for Epidiolex
Intervention Trials
Syndrome 11
Epilepsy 8
Seizures 7
Disease 6
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Clinical Trial Locations for Epidiolex

Trials by Country

Trials by Country for Epidiolex
Location Trials
United States 160
United Kingdom 8
Spain 8
Poland 4
Netherlands 4
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Trials by US State

Trials by US State for Epidiolex
Location Trials
New York 14
Texas 10
Massachusetts 10
California 10
Florida 9
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Clinical Trial Progress for Epidiolex

Clinical Trial Phase

Clinical Trial Phase for Epidiolex
Clinical Trial Phase Trials
Phase 4 8
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Epidiolex
Clinical Trial Phase Trials
Recruiting 19
Completed 17
Not yet recruiting 8
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Clinical Trial Sponsors for Epidiolex

Sponsor Name

Sponsor Name for Epidiolex
Sponsor Trials
GW Research Ltd 17
Hurd,Yasmin, Ph.D. 3
GW Pharmaceuticals Ltd. 3
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Sponsor Type

Sponsor Type for Epidiolex
Sponsor Trials
Other 52
Industry 23
NIH 4
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