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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2024

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At a glance

  • Drugs Trofinetide (Primary)
  • Indications Rett syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms LAVENDER
  • Sponsors Acadia Pharmaceuticals

    • Most Recent Events

    • 12 Sep 2023 Results assessing Population Pharmacokinetic Modelling to Confrm Weight-Based Banded Dosing & Exposure-Response Ef- ficacy Analyses to Support Trofnetide Treatment in Rett Syndrome using this study and other 13 studies presented at the 2023 American College of Clinical Pharmacology Annual Meeting
    • 12 Sep 2023 Results assessing Population Pharmacokinetic Modelling to Predict Trofnetide Exposure & Exposure-Response Safety Analyses in Girls With Rett Syndrome Aged 2 to 4 Years presented at the 2023 American College of Clinical Pharmacology Annual Meeting
    • 13 Jul 2023 According to an Acadia Pharmaceuticals media release, the company intends to submit a New Drug Submission (NDS) for trofinetide in Canada in the next 18 months with plans for Europe, Asia and other regions to be announced at a later date.
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