Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
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; 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 Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Hot Springs | Arkansas | United States | 71913 |
2 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72205 |
3 | Pfizer Investigational Site | Carmichael | California | United States | 95608 |
4 | Pfizer Investigational Site | Fresno | California | United States | 93710 |
5 | Pfizer Investigational Site | Irvine | California | United States | 92618 |
6 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
7 | Pfizer Investigational Site | Loma Linda | California | United States | 92354 |
8 | Pfizer Investigational Site | Los Angeles | California | United States | 90033 |
9 | Pfizer Investigational Site | Oceanside | California | United States | 92056 |
10 | Pfizer Investigational Site | San Francisco | California | United States | 94109 |
11 | Pfizer Investigational Site | San Francisco | California | United States | 94143 |
12 | Pfizer Investigational Site | San Luis Obiapo | California | United States | 93401 |
13 | Pfizer Investigational Site | Walnut Creek | California | United States | 94596 |
14 | Pfizer Investigational Site | Walnut Creek | California | United States | 94598 |
15 | Pfizer Investigational Site | Denver | Colorado | United States | 80218 |
16 | Pfizer Investigational Site | Fairfield | Connecticut | United States | 06824 |
17 | Pfizer Investigational Site | New Haven | Connecticut | United States | 06510 |
18 | Pfizer Investigational Site | Wilmington | Delaware | United States | 19806 |
19 | Pfizer Investigational Site | Boca Raton | Florida | United States | 33486 |
20 | Pfizer Investigational Site | Clearwater | Florida | United States | 33761 |
21 | Pfizer Investigational Site | Fort Lauderdale | Florida | United States | 33308 |
22 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32209 |
23 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32216 |
24 | Pfizer Investigational Site | Maitland | Florida | United States | 32751 |
25 | Pfizer Investigational Site | Miami | Florida | United States | 33136 |
26 | Pfizer Investigational Site | Naples | Florida | United States | 34102 |
27 | Pfizer Investigational Site | Orlando | Florida | United States | 32806 |
28 | Pfizer Investigational Site | Palm Beach Gardens | Florida | United States | 33410 |
29 | Pfizer Investigational Site | Plantation | Florida | United States | 33324 |
30 | Pfizer Investigational Site | St. Petersburg | Florida | United States | 33703 |
31 | Pfizer Investigational Site | Tallahassee | Florida | United States | 32308 |
32 | Pfizer Investigational Site | Tampa | Florida | United States | 33614 |
33 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30303 |
34 | Pfizer Investigational Site | Conyers | Georgia | United States | 30013 |
35 | Pfizer Investigational Site | Decatur | Georgia | United States | 30033 |
36 | Pfizer Investigational Site | Savannah | Georgia | United States | 31416 |
37 | Pfizer Investigational Site | Chicago | Illinois | United States | 60610 |
38 | Pfizer Investigational Site | Chicago | Illinois | United States | 60612 |
39 | Pfizer Investigational Site | Glenbrook | Illinois | United States | 60025 |
40 | Pfizer Investigational Site | Kansas City | Kansas | United States | 66160 |
41 | Pfizer Investigational Site | Lake Charles | Louisiana | United States | 70601 |
42 | Pfizer Investigational Site | Shreveport | Louisiana | United States | 71135 |
43 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21201 |
44 | Pfizer Investigational Site | Columbia | Maryland | United States | 21044 |
45 | Pfizer Investigational Site | Frederick | Maryland | United States | 21702 |
46 | Pfizer Investigational Site | Rockville | Maryland | United States | 20850 |
47 | Pfizer Investigational Site | Boston | Massachusetts | United States | 02115 |
48 | Pfizer Investigational Site | Boston | Massachusetts | United States | 02118 |
49 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | 48104 |
50 | Pfizer Investigational Site | East Lansing | Michigan | United States | 48848 |
51 | Pfizer Investigational Site | Grand Rapids | Michigan | United States | 49525 |
52 | Pfizer Investigational Site | Southfield | Michigan | United States | 48034 |
53 | Pfizer Investigational Site | Traverse City | Michigan | United States | 49684 |
54 | Pfizer Investigational Site | Golden Valley | Minnesota | United States | 55422 |
55 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | 55455 |
56 | Pfizer Investigational Site | St. Cloud | Minnesota | United States | 56303 |
57 | Pfizer Investigational Site | Kansas City | Missouri | United States | 64108 |
58 | Pfizer Investigational Site | Springfield | Missouri | United States | 65807 |
59 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68105 |
60 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68131-2197 |
61 | Pfizer Investigational Site | Henderson | Nevada | United States | 89052 |
62 | Pfizer Investigational Site | Lebanon | New Hampshire | United States | 03766 |
63 | Pfizer Investigational Site | Morristown | New Jersey | United States | 07960 |
64 | Pfizer Investigational Site | New Brunswick | New Jersey | United States | 08901 |
65 | Pfizer Investigational Site | Ridgewood | New Jersey | United States | 07450 |
66 | Pfizer Investigational Site | Manhasset | New York | United States | 11030 |
67 | Pfizer Investigational Site | Mineola | New York | United States | 11501 |
68 | Pfizer Investigational Site | Mount Vernon | New York | United States | 10550 |
69 | Pfizer Investigational Site | New York | New York | United States | 10010 |
70 | Pfizer Investigational Site | New York | New York | United States | 10029-6501 |
71 | Pfizer Investigational Site | New York | New York | United States | 10032 |
72 | Pfizer Investigational Site | Syracuse | New York | United States | 13210 |
73 | Pfizer Investigational Site | Asheville | North Carolina | United States | 28803 |
74 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27607-6520 |
75 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73104 |
76 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73118 |
77 | Pfizer Investigational Site | Norristown | Pennsylvania | United States | 19401-3434 |
78 | Pfizer Investigational Site | Sellersville | Pennsylvania | United States | 18960 |
79 | Pfizer Investigational Site | Upland | Pennsylvania | United States | 19013-3995 |
80 | Pfizer Investigational Site | Knoxville | Tennessee | United States | 37916 |
81 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38163 |
82 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37212-3375 |
83 | Pfizer Investigational Site | Austin | Texas | United States | 78756 |
84 | Pfizer Investigational Site | Dallas | Texas | United States | 75390 |
85 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
86 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
87 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84107 |
88 | Pfizer Investigational Site | Burlington | Vermont | United States | 05401 |
89 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
90 | Pfizer Investigational Site | Bellevue | Washington | United States | 98004 |
91 | Pfizer Investigational Site | Spokane | Washington | United States | 99204 |
92 | Pfizer Investigational Site | Wenatchee | Washington | United States | 98801 |
93 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53201 |
94 | Pfizer Investigational Site | Mar Del Plata | Buenos Aires | Argentina | 7600 |
95 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1209 |
96 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1426 |
97 | Pfizer Investigational Site | Buenos Aires | Argentina | 1117 | |
98 | Pfizer Investigational Site | Buenos Aires | Argentina | 1221 | |
99 | Pfizer Investigational Site | Buenos Aires | Argentina | 1419 | |
100 | Pfizer Investigational Site | Mexico City | Mexico D.F. | Mexico | 07760 |
101 | Pfizer Investigational Site | Monterrey | Nuevo Leon | Mexico | 64000 |
102 | Pfizer Investigational Site | Carolina | Puerto Rico | 00983 |
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.- 666E-CNS-0075-021