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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00058838 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: sumanirole |
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, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease. |
| Estimated Enrollment: | 854 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | September 2004 |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35249-7340 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | |
| LaJolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94109 | |
| Pfizer Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| Pfizer Investigational Site | |
| Sunnyvale, California, United States, 94089 | |
| Pfizer Investigational Site | |
| Irvine, California, United States, 92618 | |
| Pfizer Investigational Site | |
| Concord, California, United States, 94520 | |
| Pfizer Investigational Site | |
| Walnut Creek, California, United States, 94598 | |
| Pfizer Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| Pfizer Investigational Site | |
| Oxnard, California, United States, 93030 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Fort Collins, Colorado, United States, 85624 | |
| Pfizer Investigational Site | |
| Englewood, Colorado, United States, 80113 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Fairfield, Connecticut, United States, 06430 | |
| Pfizer Investigational Site | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| Pfizer Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| Pfizer Investigational Site | |
| Maitland, Florida, United States, 32751 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33136 | |
| Pfizer Investigational Site | |
| Tallahasse, Florida, United States, 32308 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Sarasota, Florida, United States, 34243 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33703-2612 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33609-4052 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30338 | |
| Pfizer Investigational Site | |
| Savannah, Georgia, United States, 31405 | |
| Pfizer Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| Pfizer Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Elkhart, Indiana, United States, 46514 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Des Moines, Iowa, United States, 50309 | |
| Pfizer Investigational Site | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Crestview Hills, Kentucky, United States, 41017 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Maine | |
| Pfizer Investigational Site | |
| SCARBOROUGH, Maine, United States, 04074 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States | |
| Pfizer Investigational Site | |
| Frederick, Maryland, United States, 21702 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Southfield, Michigan, United States, 48034 | |
| Pfizer Investigational Site | |
| Southfield, Michigan, United States, 48034 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65807 | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65804 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89052 | |
| United States, New Hampshire | |
| Pfizer Investigational Site | |
| Lebanon, New Hampshire, United States, 03766 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Albany, New York, United States, 12208 | |
| Pfizer Investigational Site | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Asheville, North Carolina, United States, 28801 | |
| Pfizer Investigational Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45408 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45415 | |
| Pfizer Investigational Site | |
| Canfield, Ohio, United States, 44406 | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Bend, Oregon, United States, 97701 | |
| Pfizer Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97209 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Upland, Pennsylvania, United States, 19013-3995 | |
| Pfizer Investigational Site | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| 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 | |
| Wenatchee, Washington, United States, 98801 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53202 | |
| Argentina | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1419 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1221ACI | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1221 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1117 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1428 | |
| Argentina, Capital Federal | |
| Pfizer Investigational Site | |
| Buenos Aires, Capital Federal, Argentina, 1426 | |
| Pfizer Investigational Site | |
| Buenos Aires, Capital Federal, Argentina, 1209 | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Westmead, New South Wales, Australia, 2145 | |
| Pfizer Investigational Site | |
| Sydney, New South Wales, Australia, 2067 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Western Australia | |
| Pfizer Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Austria | |
| Pfizer Investigational Site | |
| Innsbruck, Austria, A-6020 | |
| Pfizer Investigational Site | |
| Wien, Austria, 1080 | |
| Pfizer Investigational Site | |
| Linz, Austria, A-4020 | |
| Pfizer Investigational Site | |
| St. Poelten, Austria, A-3100 | |
| Belgium | |
| Pfizer Investigational Site | |
| Antwerpen, Belgium, 2020 | |
| Pfizer Investigational Site | |
| Roeselaere, Belgium, 8800 | |
| Pfizer Investigational Site | |
| Tielt, Belgium, 8700 | |
| Pfizer Investigational Site | |
| Ottignies, Belgium, 1340 | |
| Pfizer Investigational Site | |
| Edegem, Belgium, 2650 | |
| Colombia, Antioquia | |
| Pfizer Investigational Site | |
| Medellin, Antioquia, Colombia, 000 | |
| Colombia, D.C. | |
| Pfizer Investigational Site | |
| Bogota, D.C., Colombia, 000 | |
| Pfizer Investigational Site | |
| Bogota, D.C., Colombia, 000 | |
| France | |
| Pfizer Investigational Site | |
| Aix En Provence, France, 13100 | |
| Pfizer Investigational Site | |
| Montbelliard, France, 25200 | |
| Pfizer Investigational Site | |
| NIMES, France, 30000 | |
| Pfizer Investigational Site | |
| Angers, France, 49100 | |
| Pfizer Investigational Site | |
| Roanne, France, 42300 | |
| Germany | |
| Pfizer Investigational Site | |
| Straubing, Germany, 94315 | |
| Pfizer Investigational Site | |
| Gera, Germany, 0755 | |
| Pfizer Investigational Site | |
| Hamburg, Germany | |
| Pfizer Investigational Site | |
| Wiesbaden, Germany | |
| Greece, Attiki | |
| Pfizer Investigational Site | |
| Athens, Attiki, Greece, 15127 | |
| Pfizer Investigational Site | |
| Athens, Attiki, Greece, 115 26 | |
| Greece, Macedonia | |
| Pfizer Investigational Site | |
| Thessaloniki, Macedonia, Greece, 546 36 | |
| Italy | |
| Pfizer Investigational Site | |
| Napoli, Italy | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50139 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10125 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20126 | |
| Pfizer Investigational Site | |
| Grosseto, Italy, 58100 | |
| Pfizer Investigational Site | |
| IMPERIA, Italy, 18100 | |
| Pfizer Investigational Site | |
| Pozzilli, Italy, 86077 | |
| Italy, LU | |
| Pfizer Investigational Site | |
| Lido di Camaiore, LU, Italy, 55043 | |
| Mexico, D.F. | |
| Pfizer Investigational Site | |
| Mexico City, D.F., Mexico | |
| Mexico, Distrito Federal | |
| Pfizer Investigational Site | |
| Mexico, Distrito Federal, Mexico, 14269 | |
| Mexico, Jalisco | |
| Pfizer Investigational Site | |
| Zapopan, Jalisco, Mexico, C.P. 45200 | |
| Peru | |
| Pfizer Investigational Site | |
| Lima, Peru, L27 | |
| Pfizer Investigational Site | |
| Lima, Peru, L13 | |
| Pfizer Investigational Site | |
| Lima, Peru, L11 | |
| Puerto Rico | |
| Pfizer Investigational Site | |
| Carolina, Puerto Rico, 00983 | |
| Pfizer Investigational Site | |
| Ponce, Puerto Rico, 00732 | |
| Spain | |
| Pfizer Investigational Site | |
| Zaragoza, Spain, 50009 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28034 | |
| Pfizer Investigational Site | |
| Burgos, Spain, 09005 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08003 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08041 | |
| Pfizer Investigational Site | |
| Avila, Spain, 05071 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| Oviedo, Spain, 33006 | |
| Spain, Barcelona | |
| Pfizer Investigational Site | |
| Terrassa, Barcelona, Spain, 08221 | |
| Spain, Guipuzcoa | |
| Pfizer Investigational Site | |
| San Sebastian, Guipuzcoa, Spain, 20012 | |
| Spain, Madrid | |
| Pfizer Investigational Site | |
| Alcala De Henares, Madrid, Spain, 28805 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | DA2APD-0075-031 |
| Study First Received: | April 14, 2003 |
| Last Updated: | June 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00058838 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
