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

NCT ID: NCT00036205

Last Updated: 2007-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

984 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sumanirole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Birmingham, Alabama, United States

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Peoria, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Concord, California, United States

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Fresno, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Luis Obiapo, California, United States

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Sunnyvale, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Fairfield, Connecticut, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Trumbull, Connecticut, United States

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Wilmington, Delaware, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Elkhart, Indiana, United States

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Des Moines, Iowa, United States

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Dubuque, Iowa, United States

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Kansas City, Kansas, United States

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Lenexa, Kansas, United States

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Crestview Hills, Kentucky, United States

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Covington, Louisiana, United States

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Lake Charles, Louisiana, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Elkridge, Maryland, United States

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Frederick, Maryland, United States

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Boston, Massachusetts, United States

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Bingham Farms, Michigan, United States

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Farmington Hills, Michigan, United States

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Grand Rapids, Michigan, United States

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Royal Oak, Michigan, United States

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Traverse City, Michigan, United States

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Fridley, Minnesota, United States

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Golden Valley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Lee's Summit, Missouri, United States

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Salisbury, Missouri, United States

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Springfield, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Morristown, New Jersey, United States

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New Brunswick, New Jersey, United States

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Manhasset, New York, United States

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Mineola, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canfield, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Norristown, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Wenatchee, Washington, United States

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Marshfield, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Barcelona, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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MedellĂ­n, Antioquia, Colombia

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Bogotá, D.C., Colombia

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Carolina, , Puerto Rico

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Countries

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United States Argentina Colombia Puerto Rico

Related Links

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Other Identifiers

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M27600011

Identifier Type: -

Identifier Source: org_study_id

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