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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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ClinicalTrials.gov Identifier: NCT02224573
Recruitment Status : Enrolling by invitation
First Posted : August 25, 2014
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Last Update Posted Date October 24, 2017
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
The incidence of adverse events and other assessments as measure of subject safety. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
The number of subjects who experienced an adverse event during the study is presented. The time frame for adverse event reporting was from enrolment to the follow-up visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02224573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
  • Mean change in quality of life, relative to the pre-randomization baseline of the Core Study, if assessed during the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Changes in the Caregiver Global Impression of Change (CGIC) or Subject Global Impression of Change score, relative to the pre-randomization baseline of the Core Study, if assessed during the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Mean percentage change in the frequencies of sub-types of seizures, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Mean percentage change in total convulsive seizure frequency, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Mean percentage change in total non-convulsive seizure frequency, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50%, ≥75%, or 100% reduction in convulsive seizures, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Number of subjects experiencing a >25% worsening, −25 to +25% no change, 25-50% improvement, 50-75% improvement or >75% improvement in convulsive seizures, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Mean percentage change in the number of drop seizures, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Mean percentage change in the number of non-drop seizures, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
  • Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50%, ≥75%, or 100% reduction in drop seizures, relative to the pre-randomization baseline of the Core Study. [ Time Frame: Subjects will be followed until market authorization is granted for GWP42003-P, in DS or LGS, or a compassionate program becomes available in the country of a particular subject, or a maximum of 3 years. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes
Official Title  ICMJE An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes.
Brief Summary To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet or Lennox-Gastaut syndromes.
Detailed Description This is a multi-center, open label extension study for patients with Dravet syndrome or Lennox-Gastaut syndrome who have previously participated in double-blind, placebo-controlled clinical studies of GWP42003-P (Core Studies). The first subject will not enroll into the open label extension study until the Data Safety Monitoring Committee has reviewed the safety data from Part A of study GWEP1332.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Dravet Syndrome
  • Lennox-Gastaut Syndrome
Intervention  ICMJE Drug: GWP42003-P
Other Names:
  • Cannabidiol
  • CBD
Study Arms  ICMJE Experimental: GWP42003-P
Intervention: Drug: GWP42003-P
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 22, 2017)
680
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2014)
350
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

• Subject has completed the treatment phase of their Core Study.

Key Exclusion Criteria:

  • Subject is currently using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) other than the investigational medicinal product (IMP) 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 C-SSRS at Visit 1.
  • Subject has been part of a clinical trial involving an IMP during the inter-study period.
  • Female subject is of child bearing potential or male subject's partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra uterine device, during the study and for 3 months thereafter (however a male condom should not be used in conjunction with a female condom).
  • Subject 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224573
Other Study ID Numbers  ICMJE GWEP1415
2014-001834-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GW Research Ltd
Study Sponsor  ICMJE GW Research Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GW Research Ltd
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP