Open label long term tolerability and Efficacy of APL-1302677 (apomorphine) in Levodoa responsive patients with PD having "OFF episodes"
ID Number 16-0072Principal Investigator(s)
Department(s) or Division(s)
Parkinson's disease affects about 1 million people in the United States. Up to 50% of those affected experience daily changes in performing motor activities, called "OFF" episodes. These include periods of time where their medication wears off before the next dose and their Parkinson's disease symptoms return, a delay in the response to their Parkinson's disease medications, a partial response to their Parkinson's disease medications or when their Parkinson's disease medications suddenly, unexpectedly stop working.
The drug that is currently available to help and quickly manage people experiencing "OFF" episodes is called apomorphine, under the brand name APOKYN®, which is given as an injection under the skin. APOKYN® is the first and only prescription medicine that reverses "OFF" episodes (wearing off of medications before the next dose and unpredictable, unexpected episodes where medication stops working) associated with advancing Parkinson's disease (PD). The effect of a single injection under the skin lasts for 60-90 minutes.
Cynapsus is developing the study drug called APL-130277, a fast-acting thin film formulation of apomorphine that is placed under the tongue and is intended to be an alternative to the injectable form of apomorphine. This study is designed to evaluate the efficacy, safety and tolerability of multiple doses of APL-130277 in patients with PD who experience motor fluctuations ("OFF"episodes).
Recruiting Patients: Yes