A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

Trial Profile

A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2017

At a glance

  • Drugs Levodopa (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Registrational
  • Acronyms OFF Phenomena
  • Sponsors Acorda Therapeutics; Civitas Therapeutics
  • Most Recent Events

    • 07 Dec 2017 According to an Acorda Therapeutics media release, the company announced the resubmission of its New Drug Application (NDA) for INBRIJA to the U.S. Food and Drug Administration (FDA).
    • 31 Oct 2017 According to an Acorda Therapeutics media release, company is planning to resubmit the INBRIJA NDA in the fourth quarter of 2017.
    • 29 Aug 2017 According to an Acorda Therapeutics media release, the company is planning a Type A meeting with the FDA to respond to the issues and to seek clarification of what additional information will be required for NDA resubmission.
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