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

Completed · Phase 2

Conditions studied: Parkinson's Disease, Movement Disorder Syndrome

In brief

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.

Key facts

Study ID

NCT00199433

Run by

Kyowa Kirin, Inc.

People needed

160

Starts

2005-05-01

Expected to finish

2006-08-01

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…

• Early PD by UKPDS criteria
• Mild to moderate difficulty daily activities
• Females: Either postmenopausal or willing to use adequate contraception

You may not qualify if…

• Unable to discontinue current PD medication
• Exposure to Levodopa for more than 1 month
• Symptoms that may suggest a diagnosis other than Parkinson's disease
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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