An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

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Brief Title

An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

Official Title

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures

Brief Summary

      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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Incidence of adverse events

Secondary Outcome

 Change in seizure frequency

Condition

Tuberous Sclerosis Complex

Intervention

GWP42003-P

Study Arms / Comparison Groups

 GWP42003-P
Description:  100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). Participants will be dosed up to a maximum of 50 mg/kg/day. Dose may be lower if Investigator judges benefit and/or tolerability issues.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

210

Start Date

August 2016

Completion Date

February 2022

Primary Completion Date

February 2022

Eligibility Criteria

        Key Inclusion Criteria:

          -  Completion of the GWEP1521 Blinded Phase
      

Gender

All

Ages

1 Year - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02544750

Organization ID

GWEP1521 Open-Label Extension

Secondary IDs

2015-002154-12

Responsible Party

Sponsor

Study Sponsor

GW Research Ltd


Study Sponsor

, , 


Verification Date

September 2018