CYNAPSUS CTH-300
Research type
Research Study
Full title
A Phase 3, 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)
IRAS ID
203044
Contact name
Ray Chaudhuri
Contact email
Sponsor organisation
Cynapsus Therapeutics Inc
Eudract number
2016-000636-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 20 days
Research summary
Up to 50% of Parkinson’s disease patients experience daily changes in the ability to perform motor activities, called “OFF” episodes. These include periods of time where their L-Dopa medication wears off before the next dose or when their L-Dopa medications suddenly, unexpectedly stop working. When people with Parkinson’s disease are properly medicated and their stiffness, slowness and walking are improved, they are said to be “ON”.
The drug that is currently available to help and quickly manage people experiencing “OFF” episodes is called apomorphine, under the brand name APO-go in the UK, which is given as an injection under the skin.
APO-go is the first and only prescription medicine that reverses “OFF” episodes (wearing off of medications before the next dose of L-Dopa and unpredictable, unexpected episodes where your medication stops working) associated with advancing Parkinson’s disease. Within 8-20 minutes of injection, apomorphine shows the ability to switch the patient with Parkinson's disease to the “ON” state. 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.
The goal of this development program, however, is to formulate a medication that provides the PD patient with an easier delivery system. It is hypothesized that an orally available formulation will be easier to use, allow quicker control over predicted “OFF” periods, be more readily accessible to the patient when unpredicted “OFF” episodes occur during activities of daily living, and potentially be used by the milder PD patient when “OFF” episodes begin during the advancement of the disease."The objective is to evaluate the efficacy and safety and tolerability of APL-130277 versus placebo in patients with Parkinson’s Disease (PD) over a 12 week period".
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0541
Date of REC Opinion
12 May 2016
REC opinion
Further Information Favourable Opinion