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A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Assess the Safety, Tolerability and Efficacy of Oral Ketamine for Patients With Rett Syndrome

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Assess the Safety, Tolerability and Efficacy of Oral Ketamine for Patients With Rett Syndrome

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Mar 2024

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At a glance

  • Drugs Ketamine (Primary)
  • Indications Rett syndrome
  • Focus Adverse reactions

    • Most Recent Events

    • 02 Feb 2023 According to a PharmaTher media release, the U.S. Food and Drug Administration has granted orphan drug designation to KETARX (racemic ketamine) for the treatment of Rett Syndrome.
    • 18 Jan 2023 According to a PharmaTher media release, the company has applied with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for ketamine to treat Rett Syndrome. Unpublished results from this study will be evaluated to support a potential Phase 3 clinical study and FDA agreement on a regulatory plan for approval which the Company may pursue.
    • 07 Nov 2022 New trial record

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