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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
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: 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

Sites / Locations

  • Pfizer Investigational Site
  • 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 and the benefit of sumanirole in quality of life measures compared to placebo

Full Information

First Posted
April 14, 2003
Last Updated
June 6, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00058838
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, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo 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
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (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, at three different dose levels, 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
854 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sumanirole
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 and the benefit of sumanirole in quality of life measures compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7340
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
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
Concord
State/Province
California
ZIP/Postal Code
94520
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
LaJolla
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
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pfizer Investigational Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
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
94115
Country
United States
Facility Name
Pfizer Investigational Site
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94089
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
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
85624
Country
United States
Facility Name
Pfizer Investigational Site
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06430
Country
United States
Facility Name
Pfizer Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
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
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
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Pfizer Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703-2612
Country
United States
Facility Name
Pfizer Investigational Site
City
Tallahasse
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4052
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
30338
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
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Pfizer Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Pfizer Investigational Site
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Pfizer Investigational Site
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
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
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
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
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
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
Las Vegas
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
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Pfizer Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Pfizer Investigational Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
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
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
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
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
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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
53202
Country
United States
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
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1221ACI
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Pfizer Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Pfizer Investigational Site
City
St. Poelten
ZIP/Postal Code
A-3100
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
1080
Country
Austria
Facility Name
Pfizer Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Roeselaere
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tielt
ZIP/Postal Code
8700
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
D.c.
ZIP/Postal Code
000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Aix En Provence
ZIP/Postal Code
13100
Country
France
Facility Name
Pfizer Investigational Site
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Pfizer Investigational Site
City
Montbelliard
ZIP/Postal Code
25200
Country
France
Facility Name
Pfizer Investigational Site
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
Pfizer Investigational Site
City
Roanne
ZIP/Postal Code
42300
Country
France
Facility Name
Pfizer Investigational Site
City
Gera
ZIP/Postal Code
0755
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
Country
Germany
Facility Name
Pfizer Investigational Site
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 26
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
15127
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
State/Province
Macedonia
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Pfizer Investigational Site
City
Lido di Camaiore
State/Province
LU
ZIP/Postal Code
55043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Imperia
ZIP/Postal Code
18100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10125
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mexico City
State/Province
D.f.
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14269
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
C.P. 45200
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L11
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L13
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
Ponce
ZIP/Postal Code
00732
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Pfizer Investigational Site
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20012
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alcala De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Pfizer Investigational Site
City
Avila
ZIP/Postal Code
05071
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Burgos
ZIP/Postal Code
09005
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=DA2APD-0075-031&StudyName=Study+evaluating+sumanirole+for+the+treatment+of+the+signs+and+symptoms+of+early+Parkinson%27s+disease
Description
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Learn more about this trial

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

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