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.

6002-INT-001

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.

2004-10-01

2007-03-01

2007-05-01

Completed

Early phase I

1100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1100}}

2024-04-25