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Trial record 4 of 8 for:    cannabidiol lennox

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd
ClinicalTrials.gov Identifier:
NCT02224573
First received: August 21, 2014
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet or Lennox-Gastaut syndromes.

Condition Intervention Phase
Epilepsy Dravet Syndrome Lennox-Gastaut Syndrome Drug: GWP42003-P Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by GW Research Ltd:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 540
Study Start Date: June 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GWP42003-P Drug: GWP42003-P
Other Names:
  • Cannabidiol
  • CBD

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.
  Eligibility

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

• Subject has completed all scheduled visits in 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 four or five 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 three 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02224573     History of Changes
Other Study ID Numbers: GWEP1415
2014-001834-27 ( EudraCT Number )
Study First Received: August 21, 2014
Last Updated: January 27, 2016

Keywords provided by GW Research Ltd:
Cannabidiol
CBD
GWP42003-P

Additional relevant MeSH terms:
Syndrome
Lennox Gastaut Syndrome
Epilepsies, Myoclonic
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on June 23, 2017