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Study Evaluating Sumanirole f...

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

Last Updated: 2006-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

854 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-09-30

Brief Summary

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The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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sumanirole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Idiopathic Parkinson's disease \< 7 years duration

Modified Hoehn and Yahr Scale Stages I through III

Age greater than or equal to 30 years old

Patients or their partners must use adequate contraceptive methods

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

Exclusion Criteria

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Little Rock, Arkansas, United States

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Concord, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Loma Linda, California, United States

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Oceanside, California, United States

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Oxnard, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Sunnyvale, California, United States

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Walnut Creek, California, United States

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Englewood, Colorado, United States

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Fort Collins, Colorado, United States

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Fairfield, Connecticut, United States

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Hartford, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Palm Beach Gardens, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tallahasse, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Elkhart, Indiana, United States

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Des Moines, Iowa, United States

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Dubuque, Iowa, United States

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Kansas City, Kansas, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Frederick, Maryland, United States

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Southfield, Michigan, United States

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Springfield, Missouri, United States

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Springfield, Missouri, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Albany, New York, United States

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The Bronx, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canfield, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Bend, Oregon, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Sellersville, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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