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)

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Mar 2018

At a glance

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

    • 30 Mar 2018 According to a Sunovion Pharmaceuticals media release, study results will be presented at a future scientific congress.
    • 29 Mar 2018 According to a Sunovion Pharmaceuticals media release, based on the data from this trial, the company has submitted a new drug application (NDA) to the U.S. FDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson's disease (PD).
    • 29 Jan 2018 According to a company media release, full results from this trial are being analyzed and will be presented at a future scientific congress. Results from the study will be used to support Sunovion's submission of a New Drug Application (NDA) for apomorphine sublingual film that is expected in spring 2018.
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