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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Trial Profile

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2019

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At a glance

  • Drugs Apomorphine (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Cynapsus Therapeutics; Sunovion Pharmaceuticals
  • Most Recent Events

    • 30 Jan 2019 According to a Sunovion Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson's symptoms otherwise controlled by medications) experienced by people living with Parkinson's disease (PD). The Agency requested additional information and analyses, but no new clinical studies are required.
    • 09 Oct 2018 Results presented at the 22nd International Congress of Parkinson's Disease and Movement Disorders
    • 09 Oct 2018 Results of titration phase (n=109) evaluating the efficacy of Apomorphine for the acute treatment of OFF episodes, presented at the 22nd International Congress of Parkinson's Disease and Movement Disorders.
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