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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: sumanirole (Drug); ropinirole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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 outcome: 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

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Buenos Aires 1117, Argentina

Pfizer Investigational Site, Buenos Aires 1221, Argentina

Pfizer Investigational Site, Buenos Aires 1419, Argentina

Pfizer Investigational Site, Carolina 00983, Puerto Rico

Pfizer Investigational Site, Hot Springs, Arkansas 71913, United States

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States

Pfizer Investigational Site, Mar Del Plata, Buenos Aires 7600, Argentina

Pfizer Investigational Site, Carmichael, California 95608, United States

Pfizer Investigational Site, Fresno, California 93710, United States

Pfizer Investigational Site, Irvine, California 92618, United States

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, Loma Linda, California 92354, United States

Pfizer Investigational Site, Los Angeles, California 90033, United States

Pfizer Investigational Site, Oceanside, California 92056, United States

Pfizer Investigational Site, San Francisco, California 94109, United States

Pfizer Investigational Site, San Francisco, California 94143, United States

Pfizer Investigational Site, San Luis Obiapo, California 93401, United States

Pfizer Investigational Site, Walnut Creek, California 94596, United States

Pfizer Investigational Site, Walnut Creek, California 94598, United States

Pfizer Investigational Site, Buenos Aires, Capital Federal 1426, Argentina

Pfizer Investigational Site, Buenos Aires, Capital Federal 1209, Argentina

Pfizer Investigational Site, Denver, Colorado 80218, United States

Pfizer Investigational Site, Fairfield, Connecticut 06824, United States

Pfizer Investigational Site, New Haven, Connecticut 06510, United States

Pfizer Investigational Site, Wilmington, Delaware 19806, United States

Pfizer Investigational Site, Boca Raton, Florida 33486, United States

Pfizer Investigational Site, Clearwater, Florida 33761, United States

Pfizer Investigational Site, Fort Lauderdale, Florida 33308, United States

Pfizer Investigational Site, Jacksonville, Florida 32209, United States

Pfizer Investigational Site, Jacksonville, Florida 32216, United States

Pfizer Investigational Site, Maitland, Florida 32751, United States

Pfizer Investigational Site, Miami, Florida 33136, United States

Pfizer Investigational Site, Naples, Florida 34102, United States

Pfizer Investigational Site, Orlando, Florida 32806, United States

Pfizer Investigational Site, Palm Beach Gardens, Florida 33410, United States

Pfizer Investigational Site, Plantation, Florida 33324, United States

Pfizer Investigational Site, St. Petersburg, Florida 33703, United States

Pfizer Investigational Site, Tallahassee, Florida 32308, United States

Pfizer Investigational Site, Tampa, Florida 33614, United States

Pfizer Investigational Site, Atlanta, Georgia 30303, United States

Pfizer Investigational Site, Conyers, Georgia 30013, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Savannah, Georgia 31416, United States

Pfizer Investigational Site, Chicago, Illinois 60610, United States

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Glenbrook, Illinois 60025, United States

Pfizer Investigational Site, Kansas City, Kansas 66160, United States

Pfizer Investigational Site, Lake Charles, Louisiana 70601, United States

Pfizer Investigational Site, Shreveport, Louisiana 71135, United States

Pfizer Investigational Site, Baltimore, Maryland 21201, United States

Pfizer Investigational Site, Columbia, Maryland 21044, United States

Pfizer Investigational Site, Frederick, Maryland 21702, United States

Pfizer Investigational Site, Rockville, Maryland 20850, United States

Pfizer Investigational Site, Boston, Massachusetts 02115, United States

Pfizer Investigational Site, Boston, Massachusetts 02118, United States

Pfizer Investigational Site, Mexico City, Mexico D.F. 07760, Mexico

Pfizer Investigational Site, Ann Arbor, Michigan 48104, United States

Pfizer Investigational Site, East Lansing, Michigan 48848, United States

Pfizer Investigational Site, Grand Rapids, Michigan 49525, United States

Pfizer Investigational Site, Southfield, Michigan 48034, United States

Pfizer Investigational Site, Traverse City, Michigan 49684, United States

Pfizer Investigational Site, Golden Valley, Minnesota 55422, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55455, United States

Pfizer Investigational Site, St. Cloud, Minnesota 56303, United States

Pfizer Investigational Site, Kansas City, Missouri 64108, United States

Pfizer Investigational Site, Springfield, Missouri 65807, United States

Pfizer Investigational Site, Omaha, Nebraska 68131-2197, United States

Pfizer Investigational Site, Omaha, Nebraska 68105, United States

Pfizer Investigational Site, Henderson, Nevada 89052, United States

Pfizer Investigational Site, Lebanon, New Hampshire 03766, United States

Pfizer Investigational Site, Morristown, New Jersey 07960, United States

Pfizer Investigational Site, New Brunswick, New Jersey 08901, United States

Pfizer Investigational Site, Ridgewood, New Jersey 07450, United States

Pfizer Investigational Site, Manhasset, New York 11030, United States

Pfizer Investigational Site, Mineola, New York 11501, United States

Pfizer Investigational Site, Mount Vernon, New York 10550, United States

Pfizer Investigational Site, New York, New York 10010, United States

Pfizer Investigational Site, New York, New York 10029-6501, United States

Pfizer Investigational Site, New York, New York 10032, United States

Pfizer Investigational Site, Syracuse, New York 13210, United States

Pfizer Investigational Site, Asheville, North Carolina 28803, United States

Pfizer Investigational Site, Raleigh, North Carolina 27607-6520, United States

Pfizer Investigational Site, Monterrey, Nuevo Leon 64000, Mexico

Pfizer Investigational Site, Oklahoma City, Oklahoma 73104, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73118, United States

Pfizer Investigational Site, Norristown, Pennsylvania 19401-3434, United States

Pfizer Investigational Site, Sellersville, Pennsylvania 18960, United States

Pfizer Investigational Site, Upland, Pennsylvania 19013-3995, United States

Pfizer Investigational Site, Knoxville, Tennessee 37916, United States

Pfizer Investigational Site, Memphis, Tennessee 38163, United States

Pfizer Investigational Site, Nashville, Tennessee 37212-3375, United States

Pfizer Investigational Site, Austin, Texas 78756, United States

Pfizer Investigational Site, Dallas, Texas 75390, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Salt Lake City, Utah 84107, United States

Pfizer Investigational Site, Burlington, Vermont 05401, United States

Pfizer Investigational Site, Richmond, Virginia 23294, United States

Pfizer Investigational Site, Bellevue, Washington 98004, United States

Pfizer Investigational Site, Spokane, Washington 99204, United States

Pfizer Investigational Site, Wenatchee, Washington 98801, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53201, United States

Additional Information

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

Starting date: December 2001
Last updated: June 6, 2006

Page last updated: August 23, 2015

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