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, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.

The primary purpose of this study is to determine whether sumanirole, at three different dose levels, 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

854

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, Argentina, 1428
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1221ACI
        • Pfizer Investigational Site
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, 1209
        • Pfizer Investigational Site
      • Buenos Aires, Capital Federal, Argentina, 1426
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2067
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Austria
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
      • Linz, Austria, A-4020
        • Pfizer Investigational Site
      • St. Poelten, Austria, A-3100
        • Pfizer Investigational Site
      • Wien, Austria, 1080
        • Pfizer Investigational Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • Pfizer Investigational Site
      • Edegem, Belgium, 2650
        • Pfizer Investigational Site
      • Ottignies, Belgium, 1340
        • Pfizer Investigational Site
      • Roeselaere, Belgium, 8800
        • Pfizer Investigational Site
      • Tielt, Belgium, 8700
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 000
        • Pfizer Investigational Site
    • D.c.
      • Bogota, D.c., Colombia, 000
        • Pfizer Investigational Site
  • France
      • Aix En Provence, France, 13100
        • Pfizer Investigational Site
      • Angers, France, 49100
        • Pfizer Investigational Site
      • Montbelliard, France, 25200
        • Pfizer Investigational Site
      • Nimes, France, 30000
        • Pfizer Investigational Site
      • Roanne, France, 42300
        • Pfizer Investigational Site
  • Germany
      • Gera, Germany, 0755
        • Pfizer Investigational Site
      • Hamburg, Germany
        • Pfizer Investigational Site
      • Straubing, Germany, 94315
        • Pfizer Investigational Site
      • Wiesbaden, Germany
        • Pfizer Investigational Site
  • Greece
    • Attiki
      • Athens, Attiki, Greece, 115 26
        • Pfizer Investigational Site
      • Athens, Attiki, Greece, 15127
        • Pfizer Investigational Site
    • Macedonia
      • Thessaloniki, Macedonia, Greece, 546 36
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50139
        • Pfizer Investigational Site
      • Grosseto, Italy, 58100
        • Pfizer Investigational Site
      • Imperia, Italy, 18100
        • Pfizer Investigational Site
      • Milano, Italy, 20126
        • Pfizer Investigational Site
      • Napoli, Italy
        • Pfizer Investigational Site
      • Pozzilli, Italy, 86077
        • Pfizer Investigational Site
      • Torino, Italy, 10125
        • Pfizer Investigational Site
    • LU
      • Lido di Camaiore, LU, Italy, 55043
        • Pfizer Investigational Site
  • Mexico
    • D.f.
      • Mexico City, D.f., Mexico
        • Pfizer Investigational Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14269
        • Pfizer Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Mexico, C.P. 45200
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, L27
        • Pfizer Investigational Site
      • Lima, Peru, L11
        • Pfizer Investigational Site
      • Lima, Peru, L13
        • Pfizer Investigational Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Pfizer Investigational Site
      • Ponce, Puerto Rico, 00732
        • Pfizer Investigational Site
  • Spain
      • Avila, Spain, 05071
        • Pfizer Investigational Site
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Barcelona, Spain, 08041
        • Pfizer Investigational Site
      • Burgos, Spain, 09005
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Oviedo, Spain, 33006
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50009
        • Pfizer Investigational Site
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Pfizer Investigational Site
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20012
        • Pfizer Investigational Site
    • Madrid
      • Alcala De Henares, Madrid, Spain, 28805
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35249-7340
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Concord, California, United States, 94520
        • Pfizer Investigational Site
      • Irvine, California, United States, 92618
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • LaJolla, California, United States, 92037
        • Pfizer Investigational Site
      • Loma Linda, California, United States, 92354
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • Oxnard, California, United States, 93030
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94109
        • Pfizer Investigational Site
      • Sunnyvale, California, United States, 94089
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Pfizer Investigational Site
      • Fort Collins, Colorado, United States, 85624
        • Pfizer Investigational Site
    • Connecticut
      • Fairfield, Connecticut, United States, 06430
        • Pfizer Investigational Site
      • Hartford, Connecticut, United States, 06106
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Maitland, Florida, United States, 32751
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34243
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33703-2612
        • Pfizer Investigational Site
      • Tallahasse, Florida, United States, 32308
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33609-4052
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31405
        • Pfizer Investigational Site
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Pfizer Investigational Site
      • Dubuque, Iowa, United States, 52001
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • Pfizer Investigational Site
      • Frederick, Maryland, United States, 21702
        • Pfizer Investigational Site
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45415
        • Pfizer Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Pfizer Investigational Site
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97209
        • Pfizer Investigational Site
    • Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
      • Upland, Pennsylvania, United States, 19013-3995
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
      • Wenatchee, Washington, United States, 98801
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • 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 < 7 years duration

Modified Hoehn and Yahr Scale Stages I through III

Age greater than or equal to 30 years old

Patients or their partners must use adequate contraceptive methods

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

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
  • 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 and the benefit of sumanirole in quality of life measures compared to placebo

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

April 1, 2003

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

April 14, 2003

First Submitted That Met QC Criteria

April 14, 2003

First Posted (ESTIMATE)

April 15, 2003

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

  • DA2APD-0075-031

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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