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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

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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: 30 Apr 2024

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At a glance

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

    • Most Recent Events

    • 23 Jul 2021 According to an Kyowa Kirin media release, European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson's, experiencing end-of-dose motor fluctuations.
    • 16 Sep 2020 Results of pooled analysis from four trials presented at the 24th International Congress of Parkinson's Disease and Movement Disorders
    • 16 Sep 2020 Results of pooled analysis from four pivotal trials presented at the 24th International Congress of Parkinson's Disease and Movement Disorders

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