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: 05 Jul 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

    • 30 Jun 2017 Status changed from recruiting to active, no longer recruiting.
    • 29 Jun 2017 According to an Acorda Therapeutics media release, based on the data from SPAN-PD and two long-term safety studies the company has submitted a New Drug Application (NDA) as a 505(b)(2) application to the U.S. FDA for INBRIJATM (CVT-301, levodopa inhalation powder). The Company anticipates the FDA will inform about submission and full review by the end of September 2017.
    • 27 Apr 2017 According to an Acorda Therapeutics media release, data from this study will be presented at the International Congress of Parkinsons Disease and Movement Disorders (MDS).
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