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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Kyowa Kirin Pharmaceutical Development, Inc.; Kyowa Kirin, Inc.
• Collaborator: Kyowa Hakko Kirin UK, Ltd.
• Treatments: Istradefylline; Levodopa

Criteria

Inclusion Criteria:

• Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018

• Non-pregnant and either not of childbearing potential or using specified contraception

Exclusion Criteria:

• History of psychotic illness

• Variant/atypical Parkinson's disease

• Cancer within 5 years of enrollment

• ALT/AST levels > 1.5 times ULN

• Seizure disorder

• Neuroleptic malignant syndrome