A single-centre, 2-part randomised, double blind trial of TMS-EDMs

  • Research type

    Research Study

  • Full title

    A 2-part, randomized, double-blind, placebo-controlled, crossover exploratory validation trial of transcranial magnetic stimulation electrodiagnostic markers (TMS-EDMS) as pharmacodynamic measures of cortical and corticospinal excitability after oral administration of cannabidiol (GWP42003-P) or cannabidivarin (GWP42006; CBDV) in healthy volunteers

  • IRAS ID

    277150

  • Contact name

    Mark Richardson

  • Contact email

    mark.richardson@kcl.ac.uk

  • Sponsor organisation

    GW Research, Ltd.

  • Eudract number

    2019-004717-13

  • Clinicaltrials.gov Identifier

    20/LO/0327, REC reference

  • Duration of Study in the UK

    0 years, 6 months, 0 days

  • Research summary

    GWP42003-P is purified CBD, a cannabinoid and GWP42006 is a cannabidivarin (CBDV) under development by GW Research Ltd. (GW) for the treatment of treatment resistant epilepsies. \n\nThe study is a 2-part, randomized, double-blind, placebo-controlled, crossover exploratory validation trial of Transcranial Magnetic Stimulation Electrodiagnostic Markers (TMS-EDMs) as pharmacodynamic measures of cortical and corticospinal excitability after oral administration of Cannabidiol (GWP42003-P; CBD) or Cannabidivarin (GWP42006; CBDV) in healthy subjects.\n\nThe TMS EDMs method will first be validated in Part 1 with GWP42003-P vs. placebo and vs. baseline (predose) prior to progressing into Part 2. \n\nPart 1 is a randomized, double-blind, placebo-controlled, 3 period, crossover trial. Approximately 15 subjects will be enrolled. Each subject will be studied on 3 separate occasions following screening, with 14 (± 1) days between dosing days. Subjects will receive a single oral dose of 1500 mg GWP42003-P on 2 occasions and placebo on 1 occasion.\n\nFollowing Part 1 the safety and tolerability data will be reviewed before progressing into Part 2.\n\nPart 2 is a randomized, double-blind, 4 period crossover trial. The sample size in Part 2 may be adjusted based on results from Part 1. Approximately 16 subjects (maximum: 32 subjects) will be enrolled. Each subject will be studied on 4 separate occasions following screening, with 14 (± 1) days between dosing days. Subjects will receive a single oral dose of GWP42003-P (150, 500, or 1500 mg) on 3 occasions and GWP42006 (1500 mg) on 1 occasion. The dose volume will be the same on all 4 occasions to maintain the trial blind. The planned doses of GWP42003-P may be adjusted based on data from Part 1.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    20/LO/0327

  • Date of REC Opinion

    20 Apr 2020

  • REC opinion

    Further Information Favourable Opinion