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An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures

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Trial Profile

An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2024

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At a glance

  • Drugs Cannabidiol (Primary) ; Antiepileptic drugs
  • Indications Epilepsy; Seizures; Tuberous sclerosis
  • Focus Adverse reactions
  • Sponsors GW Research
  • Most Recent Events

    • 15 Feb 2024 Planned End Date changed from 27 Dec 2024 to 22 Jan 2025.
    • 15 Feb 2024 Planned primary completion date changed from 29 Dec 2023 to 22 Jan 2025.
    • 12 Dec 2022 According to ClinicalTrials.gov, protocol has been amended as addition of primary end points like Plasma Concentrations of GWP42003-P and its Major Metabolites,Emergence of New Types of Seizures, and Percentage Change from Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers and Investigators, change in planned patient number, number of treatment arms from 2 to 1.
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