NCT00199420

A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 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: 580 (planned)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

To establish the efficacy of 10, 20 and 40 mg/d 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 10, 20 and 40 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 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Istradefylline (KW-6002)

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-11-01
• Completion: 2005-12-01
• First posted: 2005-09-20
• Last updated: 2024-04-25

Locations

2 sites across 1 country: United States