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A Multi-center, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Poly I:Poly C12U (Ampligen) 400 mg IV Twice Weekly Versus Placebo in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME)

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Trial Profile

A Multi-center, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Poly I:Poly C12U (Ampligen) 400 mg IV Twice Weekly Versus Placebo in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Rintatolimod (Primary)
  • Indications Chronic fatigue syndrome; Encephalomyelitis
  • Focus Registrational; Therapeutic Use
  • Sponsors AIM ImmunoTech; Hemispherx Biopharma

    • Most Recent Events

    • 02 Nov 2020 Results published in the AIM ImmunoTech Media Release.
    • 02 Nov 2020 According to an AIM ImmunoTech media release, data from this study were published in PLOS ONE, a peer-reviewed open access scientific journal published by the Public Library of Science.
    • 31 Oct 2016 Retrospective sub-group analysis results presented at the 12th International IACFS/ME Research and Clinical Conference, as per Hemispherx Biopharma media release.

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