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Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sumanirole
ropinirole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

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

Full Information

First Posted
May 8, 2002
Last Updated
June 6, 2006
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00036218
Brief Title
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
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 Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sumanirole
Intervention Type
Drug
Intervention Name(s)
ropinirole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pfizer Investigational Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Pfizer Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Pfizer Investigational Site
City
San Luis Obiapo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Pfizer Investigational Site
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Pfizer Investigational Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19806
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Pfizer Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Pfizer Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Pfizer Investigational Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Pfizer Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31416
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Glenbrook
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71135
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Pfizer Investigational Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Pfizer Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Pfizer Investigational Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48848
Country
United States
Facility Name
Pfizer Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Pfizer Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Pfizer Investigational Site
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Pfizer Investigational Site
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Pfizer Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Pfizer Investigational Site
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Pfizer Investigational Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Pfizer Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029-6501
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Pfizer Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Pfizer Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401-3434
Country
United States
Facility Name
Pfizer Investigational Site
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Pfizer Investigational Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013-3995
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-3375
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Pfizer Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Pfizer Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Facility Name
Pfizer Investigational Site
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1209
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1117
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1419
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Mexico City
State/Province
Mexico D.F.
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=666E-CNS-0075-021&StudyName=Study+evaluating+sumanirole+for+the+treatment+of+the+signs+and+symptoms+of+early+Parkinson%27s+disease%2E
Description
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Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

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