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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00036218 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: sumanirole Drug: ropinirole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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. |
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | April 2003 |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| Pfizer Investigational Site | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Pfizer Investigational Site | |
| Fresno, California, United States, 93710 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94109 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94143 | |
| Pfizer Investigational Site | |
| San Luis Obiapo, California, United States, 93401 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| Pfizer Investigational Site | |
| Carmichael, California, United States, 95608 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| Walnut Creek, California, United States, 94596 | |
| Pfizer Investigational Site | |
| Irvine, California, United States, 92618 | |
| Pfizer Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| Pfizer Investigational Site | |
| Walnut Creek, California, United States, 94598 | |
| Pfizer Investigational Site | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06510 | |
| Pfizer Investigational Site | |
| Fairfield, Connecticut, United States, 06824 | |
| United States, Delaware | |
| Pfizer Investigational Site | |
| Wilmington, Delaware, United States, 19806 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| Pfizer Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| Pfizer Investigational Site | |
| Clearwater, Florida, United States, 33761 | |
| Pfizer Investigational Site | |
| Plantation, Florida, United States, 33324 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33136 | |
| Pfizer Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| Pfizer Investigational Site | |
| Naples, Florida, United States, 34102 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33703 | |
| Pfizer Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| Pfizer Investigational Site | |
| Maitland, Florida, United States, 32751 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30303 | |
| Pfizer Investigational Site | |
| Savannah, Georgia, United States, 31416 | |
| Pfizer Investigational Site | |
| Conyers, Georgia, United States, 30013 | |
| Pfizer Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60610 | |
| Pfizer Investigational Site | |
| Glenbrook, Illinois, United States, 60025 | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71135 | |
| Pfizer Investigational Site | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| Pfizer Investigational Site | |
| Frederick, Maryland, United States, 21702 | |
| Pfizer Investigational Site | |
| Rockville, Maryland, United States, 20850 | |
| Pfizer Investigational Site | |
| Columbia, Maryland, United States, 21044 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Southfield, Michigan, United States, 48034 | |
| Pfizer Investigational Site | |
| Grand Rapids, Michigan, United States, 49525 | |
| Pfizer Investigational Site | |
| Traverse City, Michigan, United States, 49684 | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48104 | |
| Pfizer Investigational Site | |
| East Lansing, Michigan, United States, 48848 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| Pfizer Investigational Site | |
| St. Cloud, Minnesota, United States, 56303 | |
| Pfizer Investigational Site | |
| Golden Valley, Minnesota, United States, 55422 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65807 | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68105 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89052 | |
| United States, New Hampshire | |
| Pfizer Investigational Site | |
| Lebanon, New Hampshire, United States, 03766 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| New Brunswick, New Jersey, United States, 08901 | |
| Pfizer Investigational Site | |
| Ridgewood, New Jersey, United States, 07450 | |
| Pfizer Investigational Site | |
| Morristown, New Jersey, United States, 07960 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10032 | |
| Pfizer Investigational Site | |
| Manhasset, New York, United States, 11030 | |
| Pfizer Investigational Site | |
| Mount Vernon, New York, United States, 10550 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10029-6501 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10010 | |
| Pfizer Investigational Site | |
| Mineola, New York, United States, 11501 | |
| Pfizer Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27607-6520 | |
| Pfizer Investigational Site | |
| Asheville, North Carolina, United States, 28803 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Norristown, Pennsylvania, United States, 19401-3434 | |
| Pfizer Investigational Site | |
| Upland, Pennsylvania, United States, 19013-3995 | |
| Pfizer Investigational Site | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38163 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37212-3375 | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78756 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Vermont | |
| Pfizer Investigational Site | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99204 | |
| Pfizer Investigational Site | |
| Bellevue, Washington, United States, 98004 | |
| Pfizer Investigational Site | |
| Wenatchee, Washington, United States, 98801 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53201 | |
| Argentina | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1117 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1221 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1419 | |
| Argentina, Buenos Aires | |
| Pfizer Investigational Site | |
| Mar Del Plata, Buenos Aires, Argentina, 7600 | |
| Argentina, Capital Federal | |
| Pfizer Investigational Site | |
| Buenos Aires, Capital Federal, Argentina, 1426 | |
| Pfizer Investigational Site | |
| Buenos Aires, Capital Federal, Argentina, 1209 | |
| Mexico, Mexico D.F. | |
| Pfizer Investigational Site | |
| Mexico City, Mexico D.F., Mexico, 07760 | |
| Mexico, Nuevo Leon | |
| Pfizer Investigational Site | |
| Monterrey, Nuevo Leon, Mexico, 64000 | |
| Puerto Rico | |
| Pfizer Investigational Site | |
| Carolina, Puerto Rico, 00983 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | 666E-CNS-0075-021 |
| Study First Received: | May 8, 2002 |
| Last Updated: | June 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00036218 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Ropinirole Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |
