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

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT00199368

Run by

Kyowa Kirin, Inc.

People needed

1100

Starts

2004-10-01

Expected to finish

2007-05-01

Last updated by the study team

2024-04-25

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kyowa Pharmaceutical Inc. — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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