NCT00199407

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

A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (planned)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Detailed description

To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline as compared to placebo.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Istradefylline (KW-6002)

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-11-01
• Completion: 2006-01-01
• First posted: 2005-09-20
• Last updated: 2024-04-25

Locations

1 site across 1 country: United States