NCT00455507

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa.

Detailed description

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/day 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Istradefylline	Two 10 mg KW-6002 tablets orally once daily for 12 weeks
DRUG	Istradefylline	Two 20 mg tablets orally once a day for 12 weeks
DRUG	Placebo	Two placebo tablets orally once daily for 12 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-04-03
• Last updated: 2012-08-29

Locations

1 site across 1 country: Japan