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A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease

Trial Profile

A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Aug 2019

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At a glance

  • Drugs Istradefylline (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms KW6002
  • Sponsors Kyowa Hakko Kirin
  • Most Recent Events

    • 28 Aug 2019 According to a Kyowa Hakko Kirin media release, U.S. Food and Drug Administration (FDA) has granted approval for NOURIAN (istradefylline) for use as adjunctive treatment to levodopa carbidopa in adult patients with Parkinson disease experiencing OFF episodes
    • 13 Dec 2016 According to a Kyowa Hakko Kirin media release, will present further findings including those from the secondary outcome measures at upcoming scientific congresses and/or in scientific journals. The company is planning to discuss with FDA for potential submission.
    • 13 Dec 2016 Top-line results published in a Kyowa Hakko Kirin media release.
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