NCT00199355

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

Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

To establish the efficacy of 20 mg/day and 40 mg/day doses 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 20 mg/d and 40mg/d doses 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 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d 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 (KW-6002)

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-09-20
• Last updated: 2014-05-23

Locations

1 site across 1 country: Japan