NCT00199394

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (planned)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.

Detailed description

Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for PD, but as the disease progresses the drug tends to become less helpful. This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and ON-OFF phenomenon. Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo. The safety and efficacy of Entacapone will also be compared to placebo.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Istradefylline (KW-6002)

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-10-01
• Completion: 2005-11-01
• First posted: 2005-09-20
• Last updated: 2024-04-25

Locations

1 site across 1 country: United Kingdom