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
NCT00036218
Collaborator
(none)
600
102
16
5.9
0.4

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

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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.
Study Start Date :
Dec 1, 2001
Study Completion Date :
Apr 1, 2003

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
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

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.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00036218
Other Study ID Numbers:
  • 666E-CNS-0075-021
First Posted:
May 9, 2002
Last Update Posted:
Jun 7, 2006
Last Verified:
Jun 1, 2006
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2006