drugset / Trial / NCT01283594

Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

NCT01283594

Phase 2/3 Completed 420 enrolled Biotie Therapies Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Timeline

Start
2011-03
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tozadenant Small molecule 60 mg Oral
Subject Tozadenant Small molecule 120 mg Oral
Subject Tozadenant Small molecule 180 mg Oral
Subject Tozadenant Small molecule 240 mg Oral
Background Levodopa Small molecule Intravenous

Indications