Clinical Study

Parkinson's Patients Who Currently Use Levodopa But Experience Off Episodes To Test An Investigational Study Drug

Posted Date: Feb 7, 2017

  • Investigator: Alberto Espay
  • Specialties: Parkinson's Disease, Neurology
  • Type of Study: Drug

Parkinson’s disease (PD) 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 your medication wears off before the next dose and your Parkinson’s disease symptoms return, a delay in the response to your Parkinson’s disease medications, a partial response to your Parkinson’s disease medications or when your Parkinson’s disease 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 APOKYN®, which is given as an injection under the skin. Apomorphine is from a class of drugs called non-ergot dopamine agonists. It was first used as a treatment for Parkinson's disease as early as 1951, and its use in medical care was first reported in 1970. 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 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. This study is designed to determine the effectiveness, safety, and tolerability of multiple treatments of APL-130277 in patients with Parkinson’s disease who experience OFF episodes.

Criteria:

You Have Been Asked To Participate In This Study Because You Have A Clinical Diagnosis Of Parkinson’S Disease, With At Least One “Off” Episode Per Day And A Total Daily “Off” Time Of 2 Hours Or More. There Will Be A Total Of Approximately 126 Patients Participating In This Study.

Keywords:

Apomorphine, Levodopa, Parkinson's Disease, Off Time, Dr. Espay

For More Information:

Kristy Espay
513-558-6517
kristy.espay@uc.edu


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