NCT00199433

A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Detailed description

Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease. This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

Conditions

• Parkinson's Disease
• Movement Disorder Syndrome

Interventions

Type	Name	Description
DRUG	Istradefylline (KW-6002)

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-07-01
• Completion: 2006-08-01
• First posted: 2005-09-20
• Last updated: 2024-04-25

Locations

1 site across 1 country: United States