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

NCT ID: NCT00036218

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

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-04-30

Brief Summary

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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.

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

ropinirole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

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

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Fresno, 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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Los Angeles, California, United States

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Oceanside, 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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San Luis Obiapo, California, United States

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Walnut Creek, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Fairfield, Connecticut, United States

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New Haven, Connecticut, United States

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Wilmington, Delaware, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, 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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Naples, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Conyers, Georgia, United States

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Decatur, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Glenbrook, Illinois, United States

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Kansas City, Kansas, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Frederick, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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East Lansing, Michigan, United States

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Grand Rapids, Michigan, United States

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Southfield, Michigan, United States

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Traverse City, Michigan, United States

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Golden Valley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Lebanon, New Hampshire, United States

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Morristown, New Jersey, United States

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New Brunswick, New Jersey, United States

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Ridgewood, New Jersey, United States

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Manhasset, New York, United States

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Mineola, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Raleigh, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Norristown, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Spokane, Washington, United States

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Wenatchee, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Carolina, , Puerto Rico

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Countries

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United States Argentina Mexico Puerto Rico

Related Links

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Other Identifiers

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666E-CNS-0075-021

Identifier Type: -

Identifier Source: org_study_id