Status:
COMPLETED
A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
Lead Sponsor:
Kyowa Kirin, Inc.
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
Conditions:
Parkinson's Disease
Movement Disorder Syndrome
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches inclu...
Eligibility Criteria
Inclusion
- Early PD by UKPDS criteria
- Mild to moderate difficulty daily activities
- Females: Either postmenopausal or willing to use adequate contraception
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00199433
Start Date
May 1 2005
End Date
August 1 2006
Last Update
April 25 2024
Active Locations (1)
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1
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540