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Last Updated: August 8, 2020

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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 Enrolling by invitation 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. Additionally, patients will undergo EEG monitoring via a Blink-EEG protocol for objective data measurements of changes induced by CBD in Blepharospasm patients. Independent second measures will be of blink kinematic analysis of review of video recording. Results would also be correlated with the Blepharospasm Severity Disability Index, Modified CDQ-24 scale and Jankovic Rating Scale. To assess any change in anxiety that might be relevant to therapeutic effect, the anxiety scale GAD-7 survey will also be administered and correlated with the results. 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 Enrolling by invitation 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. Additionally, patients will undergo EEG monitoring via a Blink-EEG protocol for objective data measurements of changes induced by CBD in Blepharospasm patients. Independent second measures will be of blink kinematic analysis of review of video recording. Results would also be correlated with the Blepharospasm Severity Disability Index, Modified CDQ-24 scale and Jankovic Rating Scale. To assess any change in anxiety that might be relevant to therapeutic effect, the anxiety scale GAD-7 survey will also be administered and correlated with the results. 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 Enrolling by invitation 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. Additionally, patients will undergo EEG monitoring via a Blink-EEG protocol for objective data measurements of changes induced by CBD in Blepharospasm patients. Independent second measures will be of blink kinematic analysis of review of video recording. Results would also be correlated with the Blepharospasm Severity Disability Index, Modified CDQ-24 scale and Jankovic Rating Scale. To assess any change in anxiety that might be relevant to therapeutic effect, the anxiety scale GAD-7 survey will also be administered and correlated with the results. 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 Enrolling by invitation 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. Additionally, patients will undergo EEG monitoring via a Blink-EEG protocol for objective data measurements of changes induced by CBD in Blepharospasm patients. Independent second measures will be of blink kinematic analysis of review of video recording. Results would also be correlated with the Blepharospasm Severity Disability Index, Modified CDQ-24 scale and Jankovic Rating Scale. To assess any change in anxiety that might be relevant to therapeutic effect, the anxiety scale GAD-7 survey will also be administered and correlated with the results. 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 2014-02-01 A study to compare the change in symptom severity in patients with schizophrenia or related psychotic disorder when treated with GWP42003 or placebo, added to existing anti-psychotic therapy over a period of six weeks. Secondary objectives are to evaluate the effect of GWP42003 on quality of life and cognition and to assess the safety and tolerability of GWP42003.
NCT02332655 Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome Active, not recruiting Faneca 66 Foundation Phase 1/Phase 2 2014-12-01 The purpose of this study is to determine the tolerability and optimal dose of cannabidiol (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome (SWS) and drug resistant epilepsy.
NCT02332655 Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome Active, not recruiting GW Pharmaceuticals Ltd. Phase 1/Phase 2 2014-12-01 The purpose of this study is to determine the tolerability and optimal dose of cannabidiol (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome (SWS) and drug resistant epilepsy.
NCT02332655 Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome Active, not recruiting Anne Comi, MD Phase 1/Phase 2 2014-12-01 The purpose of this study is to determine the tolerability and optimal dose of cannabidiol (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome (SWS) and drug resistant epilepsy.
NCT02397863 Epidiolex and Drug Resistant Epilepsy in Children Available State of Georgia N/A 2014-12-01 This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.
NCT02397863 Epidiolex and Drug Resistant Epilepsy in Children Available Augusta University N/A 2014-12-01 This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.
NCT02564952 An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol Active, not recruiting GW Research Ltd Phase 2 2016-01-01 This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Epidiolex

Condition Name

Condition Name for Epidiolex
Intervention Trials
Epilepsy 7
CBD 2
RTT 2
Rett Syndrome 2
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Condition MeSH

Condition MeSH for Epidiolex
Intervention Trials
Epilepsy 4
Syndrome 3
Disease 3
Rett Syndrome 2
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Clinical Trial Locations for Epidiolex

Trials by Country

Trials by Country for Epidiolex
Location Trials
United States 51
United Kingdom 4
Spain 2
Romania 2
Australia 1
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Trials by US State

Trials by US State for Epidiolex
Location Trials
Massachusetts 5
Alabama 4
Maryland 4
California 3
Texas 3
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Clinical Trial Progress for Epidiolex

Clinical Trial Phase

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

Clinical Trial Status for Epidiolex
Clinical Trial Phase Trials
Not yet recruiting 10
Recruiting 5
Active, not recruiting 3
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Clinical Trial Sponsors for Epidiolex

Sponsor Name

Sponsor Name for Epidiolex
Sponsor Trials
GW Research Ltd 8
University of Alabama at Birmingham 2
GW Pharmaceuticals Ltd. 2
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Sponsor Type

Sponsor Type for Epidiolex
Sponsor Trials
Other 18
Industry 10
NIH 2
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