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

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00036205
First received: May 8, 2002
Last updated: January 17, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: sumanirole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Estimated Enrollment: 984
Study Start Date: August 2000
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036205

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Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States
United States, Arizona
Pfizer Investigational Site
Peoria, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States
United States, California
Pfizer Investigational Site
Concord, California, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
La Jolla, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Luis Obiapo, California, United States
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Sunnyvale, California, United States
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Walnut Creek, California, United States
United States, Colorado
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Denver, Colorado, United States
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Englewood, Colorado, United States
United States, Connecticut
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Fairfield, Connecticut, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Trumbull, Connecticut, United States
United States, Delaware
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Wilmington, Delaware, United States
United States, Florida
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Plantation, Florida, United States
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Sarasota, Florida, United States
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St Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Indiana
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Elkhart, Indiana, United States
United States, Iowa
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Des Moines, Iowa, United States
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Dubuque, Iowa, United States
United States, Kansas
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Kansas City, Kansas, United States
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Lenexa, Kansas, United States
United States, Kentucky
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Crestview Hills, Kentucky, United States
United States, Louisiana
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Covington, Louisiana, United States
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Lake Charles, Louisiana, United States
United States, Maine
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Scarborough, Maine, United States
United States, Maryland
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Baltimore, Maryland, United States
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Elkridge, Maryland, United States
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Frederick, Maryland, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Michigan
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Bingham Farms, Michigan, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Royal Oak, Michigan, United States
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Traverse City, Michigan, United States
United States, Minnesota
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Fridley, Minnesota, United States
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Golden Valley, Minnesota, United States
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Minneapolis, Minnesota, United States
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St. Cloud, Minnesota, United States
United States, Missouri
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Lee's Summit, Missouri, United States
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Salisbury, Missouri, United States
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Springfield, Missouri, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, Nevada
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Las Vegas, Nevada, United States
United States, New Hampshire
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Lebanon, New Hampshire, United States
United States, New Jersey
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Morristown, New Jersey, United States
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New Brunswick, New Jersey, United States
United States, New York
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Manhasset, New York, United States
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Mineola, New York, United States
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Mount Vernon, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
United States, North Carolina
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
United States, Ohio
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Canfield, Ohio, United States
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Dayton, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
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Eugene, Oregon, United States
United States, Pennsylvania
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Norristown, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Upland, Pennsylvania, United States
United States, Tennessee
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
United States, Utah
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Salt Lake City, Utah, United States
United States, Vermont
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Burlington, Vermont, United States
United States, Virginia
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Charlottesville, Virginia, United States
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Richmond, Virginia, United States
United States, Washington
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Bellevue, Washington, United States
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Wenatchee, Washington, United States
United States, Wisconsin
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Marshfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Argentina
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Buenos Aires, Barcelona, Argentina
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Mar Del Plata, Buenos Aires, Argentina
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Buenos Aires, Capital Federal, Argentina
Pfizer Investigational Site
Buenos Aires, Argentina
Colombia
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Medellin, Antioquia, Colombia
Pfizer Investigational Site
Bogota, D.c., Colombia
Puerto Rico
Pfizer Investigational Site
Carolina, Puerto Rico
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00036205     History of Changes
Other Study ID Numbers: M27600011
Study First Received: May 8, 2002
Last Updated: January 17, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 20, 2014