Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00058838
Collaborator
(none)
854
135
17.1
6.3
0.4
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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.
Study Start Date
:
Apr 1, 2003
Study Completion Date
:
Sep 1, 2004
Outcome Measures
Primary Outcome Measures
- 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 Measures
- To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo []
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 0 Years
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35249-7340 |
| 2 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35294 |
| 3 | Pfizer Investigational Site | Huntsville | Alabama | United States | 35801 |
| 4 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 5 | Pfizer Investigational Site | Concord | California | United States | 94520 |
| 6 | Pfizer Investigational Site | Irvine | California | United States | 92618 |
| 7 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 8 | Pfizer Investigational Site | LaJolla | California | United States | 92037 |
| 9 | Pfizer Investigational Site | Loma Linda | California | United States | 92354 |
| 10 | Pfizer Investigational Site | Oceanside | California | United States | 92056 |
| 11 | Pfizer Investigational Site | Oxnard | California | United States | 93030 |
| 12 | Pfizer Investigational Site | San Francisco | California | United States | 94109 |
| 13 | Pfizer Investigational Site | San Francisco | California | United States | 94115 |
| 14 | Pfizer Investigational Site | Sunnyvale | California | United States | 94089 |
| 15 | Pfizer Investigational Site | Walnut Creek | California | United States | 94598 |
| 16 | Pfizer Investigational Site | Englewood | Colorado | United States | 80113 |
| 17 | Pfizer Investigational Site | Fort Collins | Colorado | United States | 85624 |
| 18 | Pfizer Investigational Site | Fairfield | Connecticut | United States | 06430 |
| 19 | Pfizer Investigational Site | Hartford | Connecticut | United States | 06106 |
| 20 | Pfizer Investigational Site | Fort Lauderdale | Florida | United States | 33308 |
| 21 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32216 |
| 22 | Pfizer Investigational Site | Maitland | Florida | United States | 32751 |
| 23 | Pfizer Investigational Site | Miami | Florida | United States | 33136 |
| 24 | Pfizer Investigational Site | Palm Beach Gardens | Florida | United States | 33410 |
| 25 | Pfizer Investigational Site | Sarasota | Florida | United States | 34243 |
| 26 | Pfizer Investigational Site | St. Petersburg | Florida | United States | 33701 |
| 27 | Pfizer Investigational Site | St. Petersburg | Florida | United States | 33703-2612 |
| 28 | Pfizer Investigational Site | Tallahasse | Florida | United States | 32308 |
| 29 | Pfizer Investigational Site | Tampa | Florida | United States | 33609-4052 |
| 30 | Pfizer Investigational Site | Tampa | Florida | United States | 33614 |
| 31 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30338 |
| 32 | Pfizer Investigational Site | Decatur | Georgia | United States | 30033 |
| 33 | Pfizer Investigational Site | Marietta | Georgia | United States | 30060 |
| 34 | Pfizer Investigational Site | Savannah | Georgia | United States | 31405 |
| 35 | Pfizer Investigational Site | Elkhart | Indiana | United States | 46514 |
| 36 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50309 |
| 37 | Pfizer Investigational Site | Dubuque | Iowa | United States | 52001 |
| 38 | Pfizer Investigational Site | Kansas City | Kansas | United States | 66160 |
| 39 | Pfizer Investigational Site | Crestview Hills | Kentucky | United States | 41017 |
| 40 | Pfizer Investigational Site | Lexington | Kentucky | United States | 40503 |
| 41 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40202 |
| 42 | Pfizer Investigational Site | Scarborough | Maine | United States | 04074 |
| 43 | Pfizer Investigational Site | Baltimore | Maryland | United States | |
| 44 | Pfizer Investigational Site | Frederick | Maryland | United States | 21702 |
| 45 | Pfizer Investigational Site | Southfield | Michigan | United States | 48034 |
| 46 | Pfizer Investigational Site | Springfield | Missouri | United States | 65804 |
| 47 | Pfizer Investigational Site | Springfield | Missouri | United States | 65807 |
| 48 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89052 |
| 49 | Pfizer Investigational Site | Lebanon | New Hampshire | United States | 03766 |
| 50 | Pfizer Investigational Site | Albany | New York | United States | 12208 |
| 51 | Pfizer Investigational Site | Bronx | New York | United States | 10461 |
| 52 | Pfizer Investigational Site | Asheville | North Carolina | United States | 28801 |
| 53 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28209 |
| 54 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 55 | Pfizer Investigational Site | Canfield | Ohio | United States | 44406 |
| 56 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44195 |
| 57 | Pfizer Investigational Site | Dayton | Ohio | United States | 45408 |
| 58 | Pfizer Investigational Site | Dayton | Ohio | United States | 45415 |
| 59 | Pfizer Investigational Site | Bend | Oregon | United States | 97701 |
| 60 | Pfizer Investigational Site | Eugene | Oregon | United States | 97401 |
| 61 | Pfizer Investigational Site | Portland | Oregon | United States | 97209 |
| 62 | Pfizer Investigational Site | Sellersville | Pennsylvania | United States | 18960 |
| 63 | Pfizer Investigational Site | Upland | Pennsylvania | United States | 19013-3995 |
| 64 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 65 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 66 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
| 67 | Pfizer Investigational Site | Spokane | Washington | United States | 99204 |
| 68 | Pfizer Investigational Site | Tacoma | Washington | United States | 98405 |
| 69 | Pfizer Investigational Site | Wenatchee | Washington | United States | 98801 |
| 70 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53202 |
| 71 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1209 |
| 72 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1426 |
| 73 | Pfizer Investigational Site | Buenos Aires | Argentina | 1117 | |
| 74 | Pfizer Investigational Site | Buenos Aires | Argentina | 1221 | |
| 75 | Pfizer Investigational Site | Buenos Aires | Argentina | 1419 | |
| 76 | Pfizer Investigational Site | Buenos Aires | Argentina | 1428 | |
| 77 | Pfizer Investigational Site | Buenos Aires | Argentina | C1221ACI | |
| 78 | Pfizer Investigational Site | Sydney | New South Wales | Australia | 2067 |
| 79 | Pfizer Investigational Site | Westmead | New South Wales | Australia | 2145 |
| 80 | Pfizer Investigational Site | Herston | Queensland | Australia | 4029 |
| 81 | Pfizer Investigational Site | Adelaide | South Australia | Australia | 5000 |
| 82 | Pfizer Investigational Site | Nedlands | Western Australia | Australia | 6009 |
| 83 | Pfizer Investigational Site | Innsbruck | Austria | A-6020 | |
| 84 | Pfizer Investigational Site | Linz | Austria | A-4020 | |
| 85 | Pfizer Investigational Site | St. Poelten | Austria | A-3100 | |
| 86 | Pfizer Investigational Site | Wien | Austria | 1080 | |
| 87 | Pfizer Investigational Site | Antwerpen | Belgium | 2020 | |
| 88 | Pfizer Investigational Site | Edegem | Belgium | 2650 | |
| 89 | Pfizer Investigational Site | Ottignies | Belgium | 1340 | |
| 90 | Pfizer Investigational Site | Roeselaere | Belgium | 8800 | |
| 91 | Pfizer Investigational Site | Tielt | Belgium | 8700 | |
| 92 | Pfizer Investigational Site | Medellin | Antioquia | Colombia | 000 |
| 93 | Pfizer Investigational Site | Bogota | D.c. | Colombia | 000 |
| 94 | Pfizer Investigational Site | Aix En Provence | France | 13100 | |
| 95 | Pfizer Investigational Site | Angers | France | 49100 | |
| 96 | Pfizer Investigational Site | Montbelliard | France | 25200 | |
| 97 | Pfizer Investigational Site | Nimes | France | 30000 | |
| 98 | Pfizer Investigational Site | Roanne | France | 42300 | |
| 99 | Pfizer Investigational Site | Gera | Germany | 0755 | |
| 100 | Pfizer Investigational Site | Hamburg | Germany | ||
| 101 | Pfizer Investigational Site | Straubing | Germany | 94315 | |
| 102 | Pfizer Investigational Site | Wiesbaden | Germany | ||
| 103 | Pfizer Investigational Site | Athens | Attiki | Greece | 115 26 |
| 104 | Pfizer Investigational Site | Athens | Attiki | Greece | 15127 |
| 105 | Pfizer Investigational Site | Thessaloniki | Macedonia | Greece | 546 36 |
| 106 | Pfizer Investigational Site | Lido di Camaiore | LU | Italy | 55043 |
| 107 | Pfizer Investigational Site | Firenze | Italy | 50139 | |
| 108 | Pfizer Investigational Site | Grosseto | Italy | 58100 | |
| 109 | Pfizer Investigational Site | Imperia | Italy | 18100 | |
| 110 | Pfizer Investigational Site | Milano | Italy | 20126 | |
| 111 | Pfizer Investigational Site | Napoli | Italy | ||
| 112 | Pfizer Investigational Site | Pozzilli | Italy | 86077 | |
| 113 | Pfizer Investigational Site | Torino | Italy | 10125 | |
| 114 | Pfizer Investigational Site | Mexico City | D.f. | Mexico | |
| 115 | Pfizer Investigational Site | Mexico | Distrito Federal | Mexico | 14269 |
| 116 | Pfizer Investigational Site | Zapopan | Jalisco | Mexico | C.P. 45200 |
| 117 | Pfizer Investigational Site | Lima | Peru | L11 | |
| 118 | Pfizer Investigational Site | Lima | Peru | L13 | |
| 119 | Pfizer Investigational Site | Lima | Peru | L27 | |
| 120 | Pfizer Investigational Site | Carolina | Puerto Rico | 00983 | |
| 121 | Pfizer Investigational Site | Ponce | Puerto Rico | 00732 | |
| 122 | Pfizer Investigational Site | Terrassa | Barcelona | Spain | 08221 |
| 123 | Pfizer Investigational Site | San Sebastian | Guipuzcoa | Spain | 20012 |
| 124 | Pfizer Investigational Site | Alcala De Henares | Madrid | Spain | 28805 |
| 125 | Pfizer Investigational Site | Avila | Spain | 05071 | |
| 126 | Pfizer Investigational Site | Barcelona | Spain | 08003 | |
| 127 | Pfizer Investigational Site | Barcelona | Spain | 08035 | |
| 128 | Pfizer Investigational Site | Barcelona | Spain | 08036 | |
| 129 | Pfizer Investigational Site | Barcelona | Spain | 08041 | |
| 130 | Pfizer Investigational Site | Burgos | Spain | 09005 | |
| 131 | Pfizer Investigational Site | Madrid | Spain | 28007 | |
| 132 | Pfizer Investigational Site | Madrid | Spain | 28034 | |
| 133 | Pfizer Investigational Site | Madrid | Spain | 28040 | |
| 134 | Pfizer Investigational Site | Oviedo | Spain | 33006 | |
| 135 | Pfizer Investigational Site | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00058838
Other Study ID Numbers:
- DA2APD-0075-031
First Posted:
Apr 15, 2003
Last Update Posted:
Jun 7, 2006
Last Verified:
Jun 1, 2006
Additional relevant MeSH terms: