Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients (6002-010)

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Istradefylline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957203

6002-010

Details and patient eligibility

About

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.

Enrollment: 308 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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308 participants in 1 patient group

Istradefylline

Experimental group

Treatment:

Drug: Istradefylline