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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 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

    • 22 Sep 2021 Results of meta-analysis of 3 studies (phase 3, double-blind study of CVT-301 in patients with PD were combined with results from a 4-week, phase 2b, double-blind, placebo-controlled study and a 12-month safety study compared to an observational cohort (OC) control) assessing safety were presented at the 25th International Congress of Parkinson's Disease and Movement Disorders.
    • 16 Apr 2021 Results (n=106) assessing changes in lung function that occurred over 12 months in patients from the observational cohort of this study, published in the Respiratory Medicine
    • 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.
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