A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Pharmaceutical Development, Inc.; Kyowa Kirin, Inc.
• Treatments: Istradefylline

Criteria

Inclusion Criteria:

1. Early PD by UKPDS criteria

2. Mild to moderate difficulty daily activities

3. Females: Either postmenopausal or willing to use adequate contraception

Exclusion Criteria:

1. Unable to discontinue current PD medication

2. Exposure to Levodopa for more than 1 month

3. Symptoms that may suggest a diagnosis other than Parkinson's disease

4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests