Study Title: Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patient's Using Levodopa (TOZ-PD)
ClinicalTrails.gove Identified: NCT02453386
Clinical Trial Investigator: Cindy Zadikoff, MD
The purpose of this study is to test the effect of tozadenant tablets compared to a placebo. To evaluate the drug, you will be asked to carefully maintain an accurate record of your ON and OFF time in a home diary. Other symptoms that some patients with PD experience will be evaluated during clinic visits. This study will also lok at whether or not tozadenant decreases end of dose wearing off in PD patients and will show wha side-effects can be expected and how troublesome they may be. This portion of the study is "double-blind", which means that neither you nor y our study doctor/study team can choose or will know to which dose group y ou have been assigned (tozadenant or placebo). In the open-label phase, subjects previously given placebo will be allowed to receive tozadenant treatment.
Clinical Trial Eligibility Criteria:
- Minimum of 3 years since Parkinson's disease diagnosis
- Patients must have been taking a levodopa-containing PD medication continuously for at least the previous 12 months
- Currently experiencing end-of-dose "wearing off" with at least 2.5 hours of OFF time per day
- 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: 15 visits over 81 weeks
Treatment: APL-130277 (sublingual apomorphine thin films) or Placebo
Compensation: $50 for each study visit
IRB#: Project: STU00201468
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