Study Title: Efficacy and Safety of ADS‐5102 (Amantadine HCI) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson’s Disease Patients
Clinical Trial Investigator:Danny Bega, MD
The purpose of this study is to evaluate the effectiveness and safety of an investigational medication, ADS‐5102 (amantadine HCl) extended release capsules, for reducing levodopa induced dyskinesia in Parkinson’s Disease (PD) patients. ADS‐5102 is an extended‐release form of amantadine and is designed to be taken once daily at bedtime, providing a slow release of the drug into the blood stream.This study is randomized which means you will be assigned by chance (like a flip of a coin) to receive either the study drug (amantadine HCI extended release capsules) at a dose of 340 mg, or a placebo (a matching capsule that does not contain the study drug).
Clinical Trial Eligibility Criteria:
- Age 30‐85 with a Parkinson’s disease diagnosis
- Currently taking antiparkinson’s medications, including a levodopa medication, for at least 30 days
- Experiencing troublesome dyskinesia following your levodopa dosing
- Able to understand and complete a standardized home diary, following training.
Other criteria will be reviewed during your first visit with the study staff.
Study Visits: Nine visits over 16 weeks. At the end of this study, participants may have the option to transition to a one year open-label study of the same drug, ADS-5102 (amantadine HCI) extended release capsules, lasting 55 weeks and include 9 office visits.
Compensation: Reimbursement for travel expenses. Study drug, study-related exams and evaluations, and all study tests will be provided at no charge.
For More Information: Call Joy Geallis at 312-503-4121 or via email at Joy.Geallis@northwestern.edu.