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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Nov 2021

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At a glance

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

Most Recent Events

  • 24 Sep 2019 According to Acorda Therapeutics media release, the European Commission (EC) granted Marketing Authorization for Inbrija 33 mg inhalation powder, hard capsules. The Marketing Authorization approves Inbrija for use in the 28 countries of the European Union, as well as Iceland, Norway and Liechtenstein.
  • 19 Mar 2019 According to an Acorda Therapeutics media release, the company will present the open label extension part (12-month) of this study at the Academy of Managed Care Pharmacy (AMCP) Managed Care & Specialty Pharmacy Annual Meeting (Mar 2019).
  • 03 Mar 2019 According to an Acorda Therapeutics media release, the company expects a final decision on its submitted MAA (Mar 2018), with the European Medicines Agency (EMA) before the end of 2019.

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