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

NCT00036205 | Terminated Phase 3

• 1 other identifier: M27600011
• Study Type: interventional
• Target: 984
• Locations: 4 countries
• Sites: 110

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Interventions

sumanirole DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease
• Modified Hoehn and Yahr Scale Stages 1-4
• Age over 30 years
• Previous participation in prior sumanirole studies

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (110)

Pfizer Investigational Site

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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Medellín, Antioquia, Colombia

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Bogotá, D.C., Colombia

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Carolina, Puerto Rico

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Parkinson Disease

Interventions

U 95666E

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2002
• First Posted: May 9, 2002
• Study Start: August 1, 2000
• Study Completion: December 1, 2004
• Last Updated: January 18, 2007

Record last verified: 2007-01

Locations

AR (4); PR (1); CO (2); US (103)