NCT00605553

Study to Evaluate SYN115 in Parkinson's Disease

A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.

Detailed description

This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Placebo oral capsules Placebo for 7 days
DRUG	Tozadenant	20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-01-31
• Last updated: 2017-08-08

Locations

1 site across 1 country: United States