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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
984

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2000

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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