➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Baxter
Boehringer Ingelheim
Moodys
AstraZeneca

Last Updated: May 11, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR EPIDIOLEX

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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.
>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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Epidiolex

Condition Name

Condition Name for Epidiolex
Intervention Trials
Epilepsy 7
CBD 3
Opioid Use Disorder 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Epidiolex
Intervention Trials
Epilepsy 4
Syndrome 4
Disease 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Epidiolex

Trials by Country

Trials by Country for Epidiolex
Location Trials
United States 59
United Kingdom 4
Spain 2
Romania 2
Sweden 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Epidiolex
Location Trials
Massachusetts 6
California 5
Alabama 5
Maryland 5
Texas 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Epidiolex

Clinical Trial Phase

Clinical Trial Phase for Epidiolex
Clinical Trial Phase Trials
Phase 4 5
Phase 3 3
Phase 2/Phase 3 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Epidiolex
Clinical Trial Phase Trials
Not yet recruiting 19
Recruiting 7
Active, not recruiting 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Epidiolex

Sponsor Name

Sponsor Name for Epidiolex
Sponsor Trials
GW Research Ltd 10
GW Pharmaceuticals Ltd. 3
University of Alabama at Birmingham 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Epidiolex
Sponsor Trials
Other 34
Industry 13
NIH 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Baxter
Merck
Boehringer Ingelheim
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.