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Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Terminated
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 Modified Hoehn and Yahr Scale Stages 1-4 Age over 30 years Previous participation in prior sumanirole studies Exclusion Criteria: Use of dopamine agonist medications and other medications in defined timeframe Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases Dementia History of active epilepsy within the past year Significant liver disease with defined laboratory criteria Significant renal disease with defined laboratory criteria Certain cardiac conditions Electroconvulsive therapy in the previous 90 days Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days Positive pregnancy test at Screen Unwillingness to use adequate contraceptive methods Lactating women History of stereotaxic brain surgery Malignant melanoma or history of treated melanoma

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.

Secondary Outcome Measures

Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson's Disease Rating Scale).
Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
Part III will be used to evaluate motor function.
Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.

Full Information

First Posted
May 8, 2002
Last Updated
January 17, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00036205
Brief Title
Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
Official Title
Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
984 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sumanirole
Primary Outcome Measure Information:
Title
The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.
Secondary Outcome Measure Information:
Title
Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson's Disease Rating Scale).
Title
Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
Title
Part III will be used to evaluate motor function.
Title
Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's disease Modified Hoehn and Yahr Scale Stages 1-4 Age over 30 years Previous participation in prior sumanirole studies Exclusion Criteria: Use of dopamine agonist medications and other medications in defined timeframe Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases Dementia History of active epilepsy within the past year Significant liver disease with defined laboratory criteria Significant renal disease with defined laboratory criteria Certain cardiac conditions Electroconvulsive therapy in the previous 90 days Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days Positive pregnancy test at Screen Unwillingness to use adequate contraceptive methods Lactating women History of stereotaxic brain surgery Malignant melanoma or history of treated melanoma
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
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Concord
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
Country
United States
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Pfizer Investigational Site
City
Irvine
State/Province
California
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United States
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Pfizer Investigational Site
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La Jolla
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California
Country
United States
Facility Name
Pfizer Investigational Site
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Loma Linda
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California
Country
United States
Facility Name
Pfizer Investigational Site
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Los Angeles
State/Province
California
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United States
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Pfizer Investigational Site
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Oceanside
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California
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United States
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Pfizer Investigational Site
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San Diego
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California
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United States
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Pfizer Investigational Site
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San Francisco
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California
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United States
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Pfizer Investigational Site
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San Luis Obiapo
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California
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United States
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Pfizer Investigational Site
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Sunnyvale
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California
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United States
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Pfizer Investigational Site
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Walnut Creek
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California
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United States
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Pfizer Investigational Site
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Denver
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Colorado
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United States
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Pfizer Investigational Site
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Englewood
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Colorado
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United States
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Pfizer Investigational Site
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Fairfield
State/Province
Connecticut
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United States
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Pfizer Investigational Site
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Hartford
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Connecticut
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United States
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Pfizer Investigational Site
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New Haven
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Connecticut
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United States
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Pfizer Investigational Site
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Trumbull
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Connecticut
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United States
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Pfizer Investigational Site
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Wilmington
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Delaware
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United States
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Pfizer Investigational Site
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Boca Raton
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United States
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Pfizer Investigational Site
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Clearwater
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United States
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Pfizer Investigational Site
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Fort Lauderdale
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United States
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Pfizer Investigational Site
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Jacksonville
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United States
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Pfizer Investigational Site
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Maitland
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United States
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Pfizer Investigational Site
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Miami
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United States
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Pfizer Investigational Site
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Naples
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United States
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Pfizer Investigational Site
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Orlando
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United States
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Pfizer Investigational Site
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Palm Beach Gardens
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United States
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Pfizer Investigational Site
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Plantation
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United States
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Pfizer Investigational Site
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Sarasota
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Florida
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United States
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Pfizer Investigational Site
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St Petersburg
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United States
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Pfizer Investigational Site
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Tallahassee
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United States
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Pfizer Investigational Site
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Tampa
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United States
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Pfizer Investigational Site
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Atlanta
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Georgia
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United States
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Pfizer Investigational Site
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Decatur
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Georgia
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United States
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Pfizer Investigational Site
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Marietta
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Georgia
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United States
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Pfizer Investigational Site
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Savannah
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Georgia
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United States
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Pfizer Investigational Site
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Chicago
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Illinois
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United States
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Pfizer Investigational Site
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Elkhart
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United States
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Des Moines
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Dubuque
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Kansas City
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Kansas
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United States
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Pfizer Investigational Site
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Lenexa
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United States
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Pfizer Investigational Site
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Crestview Hills
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Kentucky
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United States
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Pfizer Investigational Site
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Covington
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Louisiana
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United States
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Pfizer Investigational Site
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Lake Charles
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Louisiana
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United States
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Pfizer Investigational Site
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Scarborough
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Maine
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United States
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Pfizer Investigational Site
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Baltimore
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Maryland
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United States
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Pfizer Investigational Site
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Elkridge
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Maryland
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United States
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Pfizer Investigational Site
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Frederick
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Maryland
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United States
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Pfizer Investigational Site
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Boston
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Massachusetts
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United States
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Pfizer Investigational Site
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Bingham Farms
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Pfizer Investigational Site
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Farmington Hills
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Grand Rapids
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Royal Oak
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Traverse City
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Pfizer Investigational Site
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Fridley
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Pfizer Investigational Site
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Golden Valley
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Pfizer Investigational Site
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Minneapolis
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Pfizer Investigational Site
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St. Cloud
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Lee's Summit
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Salisbury
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Springfield
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United States
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Omaha
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Pfizer Investigational Site
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Las Vegas
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United States
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Pfizer Investigational Site
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Lebanon
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United States
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Pfizer Investigational Site
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Morristown
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United States
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Pfizer Investigational Site
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New Brunswick
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United States
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Pfizer Investigational Site
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Manhasset
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Pfizer Investigational Site
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Mineola
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Pfizer Investigational Site
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Mount Vernon
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Pfizer Investigational Site
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New York
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New York
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Pfizer Investigational Site
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Rochester
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United States
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Pfizer Investigational Site
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Syracuse
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New York
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Pfizer Investigational Site
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Asheville
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Pfizer Investigational Site
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Charlotte
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United States
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Pfizer Investigational Site
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Raleigh
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United States
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Pfizer Investigational Site
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Winston-Salem
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United States
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Pfizer Investigational Site
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Canfield
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Ohio
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United States
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Pfizer Investigational Site
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Dayton
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Pfizer Investigational Site
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Oklahoma City
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Oklahoma
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Pfizer Investigational Site
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Eugene
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Oregon
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United States
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Norristown
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Pfizer Investigational Site
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Sellersville
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Pfizer Investigational Site
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Upland
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Pfizer Investigational Site
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Knoxville
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Pfizer Investigational Site
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Memphis
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United States
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Pfizer Investigational Site
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Austin
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Pfizer Investigational Site
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Dallas
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Pfizer Investigational Site
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Houston
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Pfizer Investigational Site
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San Antonio
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Salt Lake City
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Utah
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Burlington
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Vermont
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Pfizer Investigational Site
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Charlottesville
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Virginia
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United States
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Pfizer Investigational Site
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Richmond
State/Province
Virginia
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United States
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Pfizer Investigational Site
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Bellevue
State/Province
Washington
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Pfizer Investigational Site
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Wenatchee
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United States
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Pfizer Investigational Site
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Marshfield
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Wisconsin
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United States
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Pfizer Investigational Site
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Milwaukee
State/Province
Wisconsin
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United States
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Pfizer Investigational Site
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Buenos Aires
State/Province
Barcelona
Country
Argentina
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Pfizer Investigational Site
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Mar Del Plata
State/Province
Buenos Aires
Country
Argentina
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Pfizer Investigational Site
City
Buenos Aires
State/Province
Capital Federal
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Pfizer Investigational Site
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Bogota
State/Province
D.c.
Country
Colombia
Facility Name
Pfizer Investigational Site
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Carolina
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=M27600011&StudyName=Study+of+Safety%2C+Tolerability%2C+and+Therapeutic+Response+In+Patients+With+Parkinson%27s+Disease+With+Sumanirole
Description
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Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

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