A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

Trial Profile

A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2017

At a glance

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

    • 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.
    • 05 Jun 2017 Interim results published in an Acorda Therapeutics media release.
    • 05 Jun 2017 Interim results from this trial were presented at the 2017 International Congress of Parkinson's Disease and Movement Disorders (MDS) acccording to an Acorda Therapeutics media release.
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