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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD)

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2019

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At a glance

  • Drugs Levodopa (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms SPAN-PD
  • Sponsors Acorda 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.
    • 26 Jul 2019 According to an Acorda Therapeutics media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending INBRIJA's approval by the European Commission (EC) for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
    • 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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