Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Istradefylline

Criteria

Inclusion Criteria:

1. Be willing and able to give written informed consent

2. Completion of the study 6002-009

Exclusion Criteria:

1. Mini-mental status examination score of 23 or less

2. Less than 70% of compliance in the study 6002-009

3. Emergency deviation in the study 6002-009

4. Pregnant females