Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 11 for:    cannabidiol lennox

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224573
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

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

Condition or disease Intervention/treatment Phase
Epilepsy Dravet Syndrome Lennox-Gastaut Syndrome Drug: GWP42003-P Phase 3

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). The first participant 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 681 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2015
Actual Primary Completion Date : September 24, 2020
Actual Study Completion Date : September 24, 2020


Arm Intervention/treatment
Experimental: GWP42003-P Drug: GWP42003-P
Other Names:
  • Cannabidiol
  • CBD
  • Epidiolex




Primary Outcome Measures :
  1. Number of participants with adverse events and other assessments as a measure of participant safety [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
    The number of participants 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.


Secondary Outcome Measures :
  1. Mean change in quality of life, relative to the pre-randomization baseline of the Core Study, if assessed during the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  2. Mean change in the Caregiver Global Impression of Change (CGIC) or Subject Global Impression of Change (SGIC) score, relative to the pre-randomization baseline of the Core Study, if assessed during the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  3. Mean percentage change in the frequencies of sub-types of seizures, relative to the pre-randomization baseline of the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  4. Mean percentage change in total convulsive seizure frequency, relative to the pre-randomization baseline of the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  5. Mean percentage change in total non-convulsive seizure frequency, relative to the pre-randomization baseline of the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  6. Number of participants 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: Participants 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 participant, or for a maximum of 5 years. ]
  7. Number of participants 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: Participants 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 participant, or for a maximum of 5 years. ]
  8. Mean percentage change in the number of drop seizures, relative to the pre-randomization baseline of the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  9. Mean percentage change in the number of non-drop seizures, relative to the pre-randomization baseline of the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]
  10. Number of participants with LGS 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: Participants 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 participant, or for a maximum of 5 years. ]
  11. Number of participants experiencing a >25% worsening, -25 to +25% no change, 25-50% improvement, 50-75% improvement, or >75% improvement in drop seizures, relative to the pre-randomization baseline of the Core Study [ Time Frame: Participants 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 participant, or for a maximum of 5 years. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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

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.
Layout table for additonal information
Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02224573    
Other Study ID Numbers: GWEP1415
2014-001834-27 ( EudraCT Number )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Keywords provided by GW Research Ltd:
Cannabidiol
CBD
GWP42003-P
GWPCARE5
Additional relevant MeSH terms:
Layout table for MeSH terms
Lennox Gastaut Syndrome
Epidiolex
Epilepsies, Myoclonic
Syndrome
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes
Genetic Diseases, Inborn
Anticonvulsants