Sunovion CTH-302
Research type
Research Study
Full title
A Three-Part Open Label Titration, Open Label Randomized Crossover, and Double Observer Single-Blind, Superiority Trial of APL-130277 compared to S.C. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations
IRAS ID
220795
Contact name
Ray Chaudhuri
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Inc.
Eudract number
2016-003456-70
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
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.
Sunovion Pharmaceuticals Inc. 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 demonstrate the preference of APL-130277 as a therapy for the acute and intermittent management of “OFF” episodes in patients with Parkinson’s disease (PD).Summary of Results
This is a summary of the main results of the trial. Results for each participant may have been different and are not in this summary.Did APL-130277 improve motor symptoms more than apomorphine injection when taken during “OFF” episodes?
No. MDS-UPDRS scores dropped (which means motor symptoms improved) after treatment with both APL-130277 and apomorphine injection. The overall improvement seen after participants took APL-130277 was similar to the improvement seen after participants took apomorphine injection.
After 4 weeks of treatment with APL-130277 in Part B of the trial, the estimated average MDS-UPDRS motor score dropped by 13.55 points 90 minutes after taking a dose.
After 4 weeks of treatment with apomorphine injection, the estimated average MDS-UPDRS motor score dropped by 13.78 points 90 minutes after taking a dose.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0232
Date of REC Opinion
22 Mar 2017
REC opinion
Further Information Favourable Opinion