NCT00199381

An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Detailed description

Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Istradefylline	Oral istradefylline (KW-6002) 20 or 40 mg once daily.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-20
• Last updated: 2024-05-17
• Results posted: 2013-07-30

Locations

1 site across 1 country: United States