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

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2016

At a glance

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

    • 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.
    • 13 Dec 2016 Primary endpoint has not been met. (The primary efficacy variable is change from Baseline in the total hours of awake time per day spent in the OFF state.), as reported in a Kyowa Hakko Kirin media release.
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