A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

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Brief Title

A Randomized Controlled 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
      blinded phase only will be described in this record. Participants will receive 1 of 2 doses
      of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a
      difference between GWP42003-P and placebo in their effect on seizure frequency.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)

Secondary Outcome

 Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration)

Condition

Tuberous Sclerosis Complex

Intervention

GWP42003-P

Study Arms / Comparison Groups

 25 mg/kg/day GWP42003-P
Description:  100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening).

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

224

Start Date

April 6, 2016

Completion Date

February 26, 2019

Primary Completion Date

January 22, 2019

Eligibility Criteria

        Key Inclusion Criteria:

          -  Participant has a well-documented clinical history of epilepsy.

          -  Participant has a clinical diagnosis of Tuberous Sclerosis Complex (TSC) according to
             the criteria agreed by the 2012 International TSC Consensus Conference.

          -  All medications or interventions for epilepsy (including ketogenic diet and any
             neurostimulation devices for epilepsy) must have been stable for 1 month prior to
             screening and the participant is willing to maintain a stable regimen throughout the
             trial.

        Key Exclusion Criteria:

          -  Participant has a history of pseudo-seizures.

          -  Participant has clinically significant unstable medical conditions other than
             epilepsy.

          -  Participant has an illness in the 4 weeks prior to screening or randomization, other
             than epilepsy, which in the opinion of the investigator could affect seizure
             frequency.

          -  Participant has undergone general anesthetic in the 4 weeks prior to screening or
             randomization.

          -  Participant has undergone surgery for epilepsy in the 6 months prior to screening.

          -  Participant is being considered for epilepsy surgery or any procedure involving
             general anesthesia.

          -  Participant has been taking felbamate for less than 1 year prior to screening.

          -  Participant is taking an oral mTOR inhibitor.

          -  Participant has any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the Investigational Medicinal Product (IMP), such as sesame oil.

          -  Participant has any history of suicidal behavior or any suicidal ideation of type 4 or
             5 on the C-SSRS in the last month or at screening.

          -  Participant is currently using or has in the past used recreational or medicinal
             cannabis, or cannabinoid-based medications, within the 3 months prior to screening and
             is unwilling to abstain for the duration for the study.

          -  Participant has tumor growth which, in the opinion of the Investigator, could affect
             the primary endpoint.

          -  Participant has significantly impaired hepatic function at the screening or
             randomization visit

          -  Participant has received an IMP within the 12 weeks prior to the screening visit.
      

Gender

All

Ages

1 Year - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT02544763

Organization ID

GWEP1521 Blinded Phase

Secondary IDs

2015-002154-12

Responsible Party

Sponsor

Study Sponsor

GW Research Ltd


Study Sponsor

, , 


Verification Date

October 2020