GWPCARE5 – An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes

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Brief Title

An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes

Official Title

An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes.

Brief Summary

      To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children
      and adults with Dravet or Lennox-Gastaut syndromes.
    

Detailed Description

      This is a multi-center, open-label extension study for participants with Dravet syndrome or
      Lennox-Gastaut syndrome who have previously participated in double-blind, placebo-controlled
      clinical studies of GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B
      [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], GWEP1424 [NCT02224703], and
      GWEP1423 [NCT02224690]). The first participant was enrolled into the open-label extension
      study after the Data Safety Monitoring Committee reviewed the safety data from Part A of
      study GWEP1332.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group

Secondary Outcome

 Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Quality of Life in Childhood Epilepsy (QOLCE) Scores

Condition

Epilepsy

Intervention

GWP42003-P

Study Arms / Comparison Groups

 GWP42003-P
Description:  

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

681

Start Date

June 11, 2015

Completion Date

September 24, 2020

Primary Completion Date

September 24, 2020

Eligibility Criteria

        Key Inclusion Criteria:

        • Participant has completed the treatment phase of their Core Studies: GWEP1332A
        [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560],
        GWEP1424 [NCT02224703], and GWEP1423 [NCT02224690].

        Key Exclusion Criteria:

          -  Participant is currently using or has in the past used recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3
             months prior to study entry other than the investigational medicinal product (IMP)
             received during the Core Study and are unwilling to abstain for the duration for the
             study.

          -  Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the
             Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.

          -  Participant has been part of a clinical trial involving an IMP during the inter-study
             period.

          -  Female participant is of child bearing potential or male participant's partner is of
             child bearing potential, unless willing to ensure that they or their partner use
             highly effective contraception, for example, hormonal contraceptives, intrauterine
             devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or
             sexual abstinence, during the study and for 3 months thereafter (however, a male
             condom should not be used in conjunction with a female condom).

          -  Participant has significantly impaired hepatic function at the 'End of Treatment'
             visit of their Core Study or at Visit 1 if re-assessed: i) Alanine aminotransferase
             (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN); ii) ALT or
             AST >3 × ULN and (total bilirubin [TBL] >2 × ULN or international normalized ratio
             [INR] >1.5); iii) ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
             right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). This
             criterion must be confirmed prior to entering the study.
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02224573

Organization ID

GWEP1415

Secondary IDs

2014-001834-27

Responsible Party

Sponsor

Study Sponsor

Jazz Pharmaceuticals


Study Sponsor

, , 


Verification Date

January 2022