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A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

Trial Profile

A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2018

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At a glance

  • Drugs Moxidectin (Primary) ; Ivermectin
  • Indications Onchocerciasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Medicines Development Limited; Pfizer; Wyeth
  • Most Recent Events

    • 13 Jun 2018 According to a United States (U.S.) Food and Drug Administration (FDA) media release, the agency has approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. The approval was based on data from this and another trial (CT profile 700244968).
    • 18 Jan 2018 Primary endpoint (Skin microfilaria density (mf/mg)) has been met, according to the results published in The Lancet
    • 18 Jan 2018 Results published in The Lancet.
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