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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

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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2025

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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

  • 31 Jan 2025 According to ClinicalTrials.gov,this study was terminated based on a strategic decision by the Sponsor.
  • 31 Jan 2025 Status changed from recruiting to discontinued.
  • 15 Feb 2024 Planned End Date changed from 27 Dec 2024 to 22 Jan 2025.

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