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Observational, Prospective, Multicenter Study of Epidyolex® (Cannabidiol CBD 100 mg/ml) Oral Solution, as Adjunctive Treatment for Seizures Associated With Lennox- Gastaut Syndrome (LGS), Dravet Syndrome (DS) and Tuberous Sclerosis Complex (TSC)

Trial Profile

Observational, Prospective, Multicenter Study of Epidyolex® (Cannabidiol CBD 100 mg/ml) Oral Solution, as Adjunctive Treatment for Seizures Associated With Lennox- Gastaut Syndrome (LGS), Dravet Syndrome (DS) and Tuberous Sclerosis Complex (TSC)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 22 May 2025

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome; Lennox-Gastaut syndrome; Tuberous sclerosis
  • Focus Therapeutic Use
  • Acronyms EpiTALY
  • Sponsors Jazz Pharmaceuticals Inc

Most Recent Events

  • 10 Feb 2025 Planned initiation date changed from 23 Dec 2024 to 23 Mar 2025.
  • 10 Feb 2025 Status changed from not yet recruiting to recruiting.
  • 11 Dec 2024 Protocol was amended to include patients with Tuberous Sclerosis Complex (TSC), hence there was a change I the primary endpoint and patient number.

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