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Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

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Trial Profile

Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Fenfluramine (Primary)
  • Indications Dravet syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ORCHID
  • Sponsors UCB Biosciences

Most Recent Events

  • 31 May 2025 Planned End Date changed from 29 Jan 2027 to 20 Nov 2026.
  • 31 May 2025 Planned primary completion date changed from 30 Oct 2026 to 3 Sep 2026.
  • 19 Sep 2024 Planned End Date changed from 2 Sep 2026 to 29 Jan 2027.

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