Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

Stopped early · Phase 3

Conditions studied: Parkinson Disease

In brief

The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.

Key facts

Study ID

NCT00036205

Run by

Pfizer

People needed

984

Starts

2000-08-01

Expected to finish

2004-12-01

Last updated by the study team

2007-01-18

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic Parkinson's disease
• Modified Hoehn and Yahr Scale Stages 1-4
• Age over 30 years
• Previous participation in prior sumanirole studies

You may not qualify if…

• Use of dopamine agonist medications and other medications in defined timeframe
• Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
• Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
• Dementia
• History of active epilepsy within the past year
• Significant liver disease with defined laboratory criteria
• Significant renal disease with defined laboratory criteria
• Certain cardiac conditions
• Electroconvulsive therapy in the previous 90 days
• Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
• Positive pregnancy test at Screen
• Unwillingness to use adequate contraceptive methods
• Lactating women
• History of stereotaxic brain surgery
• Malignant melanoma or history of treated melanoma

Where it is running

• Pfizer Investigational Site — Peoria, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Concord, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — Irvine, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Loma Linda, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — San Luis Obiapo, California, United States
• Pfizer Investigational Site — Sunnyvale, California, United States
• Pfizer Investigational Site — Walnut Creek, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Englewood, Colorado, United States
• Pfizer Investigational Site — Fairfield, Connecticut, United States
• Pfizer Investigational Site — Hartford, Connecticut, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Trumbull, Connecticut, United States
• Pfizer Investigational Site — Wilmington, Delaware, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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