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)
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History