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Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
This study has been terminated.
First Received: May 8, 2002   Last Updated: January 17, 2007   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00036205
  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 III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Sumanirole
U.S. FDA Resources

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
Tucson, Arizona, United States
Pfizer Investigational Site
Peoria, Arizona, United States
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States
United States, California
Pfizer Investigational Site
Sunnyvale, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
San Luis Obiapo, California, United States
Pfizer Investigational Site
Loma Linda, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Walnut Creek, California, United States
Pfizer Investigational Site
San Francisco, California, United States
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Concord, California, United States
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Oceanside, 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
Pfizer Investigational Site
Trumbull, Connecticut, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Hartford, Connecticut, United States
United States, Delaware
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Wilmington, Delaware, United States
United States, Florida
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States
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Plantation, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
Pfizer Investigational Site
Tallahassee, Florida, United States
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Naples, Florida, United States
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Sarasota, Florida, United States
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Maitland, Florida, United States
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Boca Raton, Florida, United States
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Orlando, Florida, United States
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St Petersburg, Florida, United States
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Jacksonville, Florida, United States
United States, Georgia
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Savannah, Georgia, United States
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Atlanta, Georgia, United States
Pfizer Investigational Site
Marietta, Georgia, United States
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Savannah, Georgia, United States
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Decatur, Georgia, United States
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Atlanta, 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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Elkridge, Maryland, United States
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Frederick, Maryland, United States
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Baltimore, Maryland, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Michigan
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Royal Oak, Michigan, United States
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Bingham Farms, Michigan, United States
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Grand Rapids, Michigan, United States
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Traverse City, Michigan, United States
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Farmington Hills, Michigan, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
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Fridley, Minnesota, United States
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St. Cloud, Minnesota, United States
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Golden Valley, Minnesota, United States
United States, Missouri
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Springfield, Missouri, United States
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Springfield, Missouri, United States
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Lee's Summit, Missouri, United States
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Salisbury, 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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New Brunswick, New Jersey, United States
Pfizer Investigational Site
Morristown, New Jersey, United States
United States, New York
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Manhasset, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
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New York, New York, United States
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Mount Vernon, New York, United States
Pfizer Investigational Site
Mineola, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
Pfizer Investigational Site
CHARLOTTE, North Carolina, United States
Pfizer Investigational Site
Asheville, North Carolina, United States
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States
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Canfield, 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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Upland, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
United States, Tennessee
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Memphis, Tennessee, United States
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Knoxville, Tennessee, United States
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Houston, Texas, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Dallas, 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
Pfizer Investigational Site
Richmond, Virginia, United States
United States, Washington
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Bellevue, Washington, United States
Pfizer Investigational Site
Wenatchee, Washington, United States
United States, Wisconsin
Pfizer Investigational Site
Marshfield, Wisconsin, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Argentina
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Buenos Aires, Argentina
Argentina, Barcelona
Pfizer Investigational Site
Buenos Aires, Barcelona, Argentina
Argentina, Buenos Aires
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Mar Del Plata, Buenos Aires, Argentina
Argentina, Capital Federal
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina
Colombia, Antioquia
Pfizer Investigational Site
Medellin, Antioquia, Colombia
Colombia, D.C.
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

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

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

ClinicalTrials.gov processed this record on November 27, 2009



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