NCT02453386

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).

Detailed description

During Part A, each patient will participate for up to 30 weeks, which includes a Screening Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind treatment: * Screening Period: 1 - 6 weeks. * Double-Blind Treatment Period: 24 weeks. After completion of Part A, patients will continue in Part B for an additional 56 weeks: * Open-Label Treatment Period: 52 weeks. * Post-Treatment Safety Follow Up: 4 weeks.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	tozadenant
DRUG	placebo

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-01-12
• Completion: 2018-01-12
• First posted: 2015-05-25
• Last updated: 2019-04-03
• Results posted: 2019-03-26

Locations

71 sites across 7 countries: United States, Austria, Canada, Czechia, Germany, Italy, Spain