NCT01283594

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Tozadenant (SYN115) 60 mg BID	Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 60 mg BID.
DRUG	Placebo	White-coated, modified-oval placebo tablets.
DRUG	Levodopa (L-dopa)	One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
DRUG	Tozadenant (SYN115) 120 mg BID	Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 120 mg BID.
DRUG	Tozadenant (SYN115) 180 mg BID	Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 180 mg BID.
DRUG	Tozadenant (SYN115) 240 mg BID	Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 240 mg BID.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-01-26
• Last updated: 2019-01-17

Locations

61 sites across 6 countries: United States, Argentina, Canada, Chile, Romania, Ukraine