A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off.
The purpose of this phase II/III study is to assess the efficacy of the drug SYN115 to reduce the length of time during the day in the “off” state for patients being treated with levodopa medications. The study will compare four different doses of SYN115 with a placebo to see how it affects movement during the “on” and “off” times. In addition, this study will investigate any side effects that patients may experience while on SYN115.
Participation in this study will last 20 weeks. Patients will be asked to take the study drug for 12 of these weeks. About 400 patients will be enrolled in this study at multiple study centers nationwide.
A previous study of SYN115 in 21 patients was completed with positive results. Researchers believe that SYN115 may help improve the symptoms of patients with Parkinson’s disease during wearing off periods.
- Diagnosis of idiopathic PD
- On levodopa and having good response
- Taken levodopa therapy for at least 12 months and experiencing end-of-dose wearing off (at least 2.5 hours of “off” time each day)
- Other PD medications are permitted but should be stable and not expected to change during the 20-week study.
- No history of surgical interventions for PD
- Other exclusions may apply – please see the link below for additional inclusion/exclusion criteria or call the study coordinator below to learn more.
*Study information also listed on ClinicalTrials.gov, here.