Parkinson Disease Clinical Trial
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.
| Verified date | June 2006 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 854 |
| Est. completion date | September 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | Capital Federal |
| Argentina | Pfizer Investigational Site | Buenos Aires | Capital Federal |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Herston | Queensland |
| Australia | Pfizer Investigational Site | Nedlands | Western Australia |
| Australia | Pfizer Investigational Site | Sydney | New South Wales |
| Australia | Pfizer Investigational Site | Westmead | New South Wales |
| Austria | Pfizer Investigational Site | Innsbruck | |
| Austria | Pfizer Investigational Site | Linz | |
| Austria | Pfizer Investigational Site | St. Poelten | |
| Austria | Pfizer Investigational Site | Wien | |
| Belgium | Pfizer Investigational Site | Antwerpen | |
| Belgium | Pfizer Investigational Site | Edegem | |
| Belgium | Pfizer Investigational Site | Ottignies | |
| Belgium | Pfizer Investigational Site | Roeselaere | |
| Belgium | Pfizer Investigational Site | Tielt | |
| Colombia | Pfizer Investigational Site | Bogota | D.c. |
| Colombia | Pfizer Investigational Site | Medellin | Antioquia |
| France | Pfizer Investigational Site | Aix En Provence | |
| France | Pfizer Investigational Site | Angers | |
| France | Pfizer Investigational Site | Montbelliard | |
| France | Pfizer Investigational Site | Nimes | |
| France | Pfizer Investigational Site | Roanne | |
| Germany | Pfizer Investigational Site | Gera | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Straubing | |
| Germany | Pfizer Investigational Site | Wiesbaden | |
| Greece | Pfizer Investigational Site | Athens | Attiki |
| Greece | Pfizer Investigational Site | Athens | Attiki |
| Greece | Pfizer Investigational Site | Thessaloniki | Macedonia |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Grosseto | |
| Italy | Pfizer Investigational Site | Imperia | |
| Italy | Pfizer Investigational Site | Lido di Camaiore | LU |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Pozzilli | |
| Italy | Pfizer Investigational Site | Torino | |
| Mexico | Pfizer Investigational Site | Mexico | Distrito Federal |
| Mexico | Pfizer Investigational Site | Mexico City | D.f. |
| Mexico | Pfizer Investigational Site | Zapopan | Jalisco |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Puerto Rico | Pfizer Investigational Site | Carolina | |
| Puerto Rico | Pfizer Investigational Site | Ponce | |
| Spain | Pfizer Investigational Site | Alcala De Henares | Madrid |
| Spain | Pfizer Investigational Site | Avila | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Burgos | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Oviedo | |
| Spain | Pfizer Investigational Site | San Sebastian | Guipuzcoa |
| Spain | Pfizer Investigational Site | Terrassa | Barcelona |
| Spain | Pfizer Investigational Site | Zaragoza | |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Asheville | North Carolina |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Bend | Oregon |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Bronx | New York |
| United States | Pfizer Investigational Site | Canfield | Ohio |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Concord | California |
| United States | Pfizer Investigational Site | Crestview Hills | Kentucky |
| United States | Pfizer Investigational Site | Dayton | Ohio |
| United States | Pfizer Investigational Site | Dayton | Ohio |
| United States | Pfizer Investigational Site | Decatur | Georgia |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Dubuque | Iowa |
| United States | Pfizer Investigational Site | Elkhart | Indiana |
| United States | Pfizer Investigational Site | Englewood | Colorado |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Fairfield | Connecticut |
| United States | Pfizer Investigational Site | Fort Collins | Colorado |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Frederick | Maryland |
| United States | Pfizer Investigational Site | Hartford | Connecticut |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntsville | Alabama |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kansas City | Kansas |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | LaJolla | California |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lebanon | New Hampshire |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Loma Linda | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Maitland | Florida |
| United States | Pfizer Investigational Site | Marietta | Georgia |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Oceanside | California |
| United States | Pfizer Investigational Site | Oxnard | California |
| United States | Pfizer Investigational Site | Palm Beach Gardens | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Sarasota | Florida |
| United States | Pfizer Investigational Site | Savannah | Georgia |
| United States | Pfizer Investigational Site | Scarborough | Maine |
| United States | Pfizer Investigational Site | Sellersville | Pennsylvania |
| United States | Pfizer Investigational Site | Southfield | Michigan |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Springfield | Missouri |
| United States | Pfizer Investigational Site | Springfield | Missouri |
| United States | Pfizer Investigational Site | St. Petersburg | Florida |
| United States | Pfizer Investigational Site | St. Petersburg | Florida |
| United States | Pfizer Investigational Site | Sunnyvale | California |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Tallahasse | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Upland | Pennsylvania |
| United States | Pfizer Investigational Site | Walnut Creek | California |
| United States | Pfizer Investigational Site | Wenatchee | Washington |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Mexico, Peru, Puerto Rico, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo |
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