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

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Istradefylline ( KW-6002)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00199368

6002-INT-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)