Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

Completed · Phase 3

Conditions studied: Parkinson Disease

In brief

The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.

Key facts

Study ID

NCT00036218

Run by

Pfizer

People needed

600

Starts

2001-12-01

Expected to finish

2003-04-01

Last updated by the study team

2006-06-07

Who can join

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

You may qualify if…

• Parkinson's disease of less than 7 years duration
• Modified Hoehn and Yahr Scale Stages 1 through 3.
• Age greater than or equal to 30 years old.
• Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.
• Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
• Levodopa received for 1-year accumulated interval in the last two years.
• Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.
• Unstable dose regimes of hypnotics, anxiolytics or antidepressants
• Dementia
• History of stereotaxic brain surgery, psychosis or active epilepsy within past year.
• Participation in clinical trial within the previous 30 days.
• Malignant melanoma or history of melanoma
• Significant medical or pshychiatric condition.

Where it is running

• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Carmichael, 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 Francisco, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — San Luis Obiapo, California, United States
• Pfizer Investigational Site — Walnut Creek, California, United States
• Pfizer Investigational Site — Walnut Creek, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Fairfield, Connecticut, United States
• Pfizer Investigational Site — New Haven, 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 — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Maitland, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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