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

NCT00036218 | Completed Phase 3

• 1 other identifier: 666E-CNS-0075-021
• Study Type: interventional
• Target: 600
• Locations: 4 countries
• Sites: 102

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo

Secondary Outcomes (1)

• To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole

Interventions

sumanirole DRUG

ropinirole DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (102)

Pfizer Investigational Site

Hot Springs, Arkansas, 71913, United States

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Little Rock, Arkansas, 72205, United States

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Carmichael, California, 95608, United States

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Fresno, California, 93710, United States

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Irvine, California, 92618, United States

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La Jolla, California, 92037, United States

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Loma Linda, California, 92354, United States

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Los Angeles, California, 90033, United States

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Oceanside, California, 92056, United States

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San Francisco, California, 94109, United States

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San Francisco, California, 94143, United States

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San Luis Obiapo, California, 93401, United States

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Walnut Creek, California, 94596, United States

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Walnut Creek, California, 94598, United States

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Denver, Colorado, 80218, United States

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Fairfield, Connecticut, 06824, United States

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New Haven, Connecticut, 06510, United States

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Wilmington, Delaware, 19806, United States

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Boca Raton, Florida, 33486, United States

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Clearwater, Florida, 33761, United States

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Fort Lauderdale, Florida, 33308, United States

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Jacksonville, Florida, 32209, United States

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Jacksonville, Florida, 32216, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33136, United States

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Naples, Florida, 34102, United States

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Orlando, Florida, 32806, United States

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Palm Beach Gardens, Florida, 33410, United States

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Plantation, Florida, 33324, United States

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St. Petersburg, Florida, 33703, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33614, United States

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Atlanta, Georgia, 30303, United States

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Conyers, Georgia, 30013, United States

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Decatur, Georgia, 30033, United States

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Savannah, Georgia, 31416, United States

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Chicago, Illinois, 60610, United States

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Chicago, Illinois, 60612, United States

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Glenbrook, Illinois, 60025, United States

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Kansas City, Kansas, 66160, United States

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Lake Charles, Louisiana, 70601, United States

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Shreveport, Louisiana, 71135, United States

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Baltimore, Maryland, 21201, United States

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Columbia, Maryland, 21044, United States

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Frederick, Maryland, 21702, United States

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Rockville, Maryland, 20850, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02118, United States

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Ann Arbor, Michigan, 48104, United States

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East Lansing, Michigan, 48848, United States

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Grand Rapids, Michigan, 49525, United States

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Southfield, Michigan, 48034, United States

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Traverse City, Michigan, 49684, United States

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Golden Valley, Minnesota, 55422, United States

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Minneapolis, Minnesota, 55455, United States

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Saint Cloud, Minnesota, 56303, United States

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Kansas City, Missouri, 64108, United States

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Springfield, Missouri, 65807, United States

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Omaha, Nebraska, 68105, United States

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Omaha, Nebraska, 68131-2197, United States

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Henderson, Nevada, 89052, United States

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Lebanon, New Hampshire, 03766, United States

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Morristown, New Jersey, 07960, United States

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New Brunswick, New Jersey, 08901, United States

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Ridgewood, New Jersey, 07450, United States

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Manhasset, New York, 11030, United States

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Mineola, New York, 11501, United States

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Mount Vernon, New York, 10550, United States

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New York, New York, 10010, United States

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New York, New York, 10029-6501, United States

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New York, New York, 10032, United States

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Syracuse, New York, 13210, United States

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Asheville, North Carolina, 28803, United States

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Raleigh, North Carolina, 27607-6520, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73118, United States

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Norristown, Pennsylvania, 19401-3434, United States

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Sellersville, Pennsylvania, 18960, United States

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Upland, Pennsylvania, 19013-3995, United States

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Knoxville, Tennessee, 37916, United States

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Memphis, Tennessee, 38163, United States

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Nashville, Tennessee, 37212-3375, United States

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Austin, Texas, 78756, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Burlington, Vermont, 05401, United States

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Richmond, Virginia, 23294, United States

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Bellevue, Washington, 98004, United States

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Spokane, Washington, 99204, United States

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Wenatchee, Washington, 98801, United States

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Milwaukee, Wisconsin, 53201, United States

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Buenos Aires, Buenos Aires, 1117, Argentina

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Buenos Aires, Buenos Aires, 1221, Argentina

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Buenos Aires, Buenos Aires, 1419, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Buenos Aires, Buenos Aires F.D., 1209, Argentina

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Buenos Aires, Buenos Aires F.D., 1426, Argentina

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Mexico City, Mexico City, 07760, Mexico

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Monterrey, Nuevo León, 64000, Mexico

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Carolina, 00983, Puerto Rico

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Parkinson Disease

Interventions

U 95666E; ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2002
• First Posted: May 9, 2002
• Study Start: December 1, 2001
• Study Completion: April 1, 2003
• Last Updated: June 7, 2006

Record last verified: 2006-06

Locations

PR (1); AR (6); ME (2); US (93)