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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-001011
    NCT ID: NCT02224573
    Sponsor Protocol Number: GWEP1415

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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 (alanine aminotransferase [ALT] >5 x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN) OR ALT or aspartate aminotransferase (AST) >3 x ULN and (TBL >2 x ULN or international normalized ratio [INR] >1.5). This criterion can only be confirmed once the laboratory results are available; subjects that entered the study and are later found not to meet this criterion should be withdrawn from the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elaine Wirrell, M.D.

Closed for enrollment

Contact information:

Spoorthi Jagadish

(507)538-5523

Jagadish.Spoorthi@mayo.edu

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CLS-20147459

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