Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

June 6, 2006 updated by: Pfizer

A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.

The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

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, 1117
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, 1221
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, 1419
        • Pfizer Investigational Site
    • Buenos Aires
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Pfizer Investigational Site
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, 1209
        • Pfizer Investigational Site
      • Buenos Aires, Capital Federal, Argentina, 1426
        • Pfizer Investigational Site
  • Mexico
    • Mexico D.F.
      • Mexico City, Mexico D.F., Mexico, 07760
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Pfizer Investigational Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Pfizer Investigational Site
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Pfizer Investigational Site
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
      • Irvine, California, United States, 92618
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Loma Linda, California, United States, 92354
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94143
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94109
        • Pfizer Investigational Site
      • San Luis Obiapo, California, United States, 93401
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94596
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
    • Delaware
      • Wilmington, Delaware, United States, 19806
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32209
        • Pfizer Investigational Site
      • Maitland, Florida, United States, 32751
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Naples, Florida, United States, 34102
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33703
        • Pfizer Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Pfizer Investigational Site
      • Conyers, Georgia, United States, 30013
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31416
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Glenbrook, Illinois, United States, 60025
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71135
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
      • Columbia, Maryland, United States, 21044
        • Pfizer Investigational Site
      • Frederick, Maryland, United States, 21702
        • Pfizer Investigational Site
      • Rockville, Maryland, United States, 20850
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Pfizer Investigational Site
      • East Lansing, Michigan, United States, 48848
        • Pfizer Investigational Site
      • Grand Rapids, Michigan, United States, 49525
        • Pfizer Investigational Site
      • Southfield, Michigan, United States, 48034
        • Pfizer Investigational Site
      • Traverse City, Michigan, United States, 49684
        • Pfizer Investigational Site
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • Pfizer Investigational Site
      • St. Cloud, Minnesota, United States, 56303
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68131-2197
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Pfizer Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
      • Ridgewood, New Jersey, United States, 07450
        • Pfizer Investigational Site
    • New York
      • Manhasset, New York, United States, 11030
        • Pfizer Investigational Site
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
      • Mount Vernon, New York, United States, 10550
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10010
        • Pfizer Investigational Site
      • New York, New York, United States, 10029-6501
        • Pfizer Investigational Site
      • Syracuse, New York, United States, 13210
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27607-6520
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401-3434
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
      • Upland, Pennsylvania, United States, 19013-3995
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38163
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37212-3375
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
      • Wenatchee, Washington, United States, 98801
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • 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

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.

Levodopa received for 1-year accumulated interval in the last two years.

Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.

Unstable dose regimes of hypnotics, anxiolytics or antidepressants

Dementia

History of stereotaxic brain surgery, psychosis or active epilepsy within past year.

Participation in clinical trial within the previous 30 days.

Malignant melanoma or history of melanoma

Significant medical or pshychiatric condition.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo

Secondary Outcome Measures

Outcome Measure
To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole

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

December 1, 2001

Study Completion

April 1, 2003

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)

June 7, 2006

Last Update Submitted That Met QC Criteria

June 6, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 666E-CNS-0075-021

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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