NCT00199368

An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (planned)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Detailed description

Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Istradefylline ( KW-6002)

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-03-01
• Completion: 2007-05-01
• First posted: 2005-09-20
• Last updated: 2024-04-25

Locations

1 site across 1 country: United States