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

January 17, 2007 updated by: Pfizer

Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

984

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

May 8, 2002

First Submitted That Met QC Criteria

May 8, 2002

First Posted (Estimate)

May 9, 2002

Study Record Updates

Last Update Posted (Estimate)

January 18, 2007

Last Update Submitted That Met QC Criteria

January 17, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M27600011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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