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

NCT00058838 | Completed Phase 3

• 1 other identifier: DA2APD-0075-031
• Study Type: interventional
• Target: 854
• Locations: 13 countries
• Sites: 130

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo

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 \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (134)

Pfizer Investigational Site

Birmingham, Alabama, 35249-7340, United States

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Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Little Rock, Arkansas, 72205, United States

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Concord, California, 94520, United States

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Irvine, California, 92618, United States

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La Jolla, California, 92037, United States

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Loma Linda, California, 92354, United States

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Oceanside, California, 92056, United States

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Oxnard, California, 93030, United States

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San Francisco, California, 94109, United States

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San Francisco, California, 94115, United States

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Sunnyvale, California, 94089, United States

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Walnut Creek, California, 94598, United States

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Englewood, Colorado, 80113, United States

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Fort Collins, Colorado, 85624, United States

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Fairfield, Connecticut, 06430, United States

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Hartford, Connecticut, 06106, United States

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Fort Lauderdale, Florida, 33308, United States

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Jacksonville, Florida, 32216, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33136, United States

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Palm Beach Gardens, Florida, 33410, United States

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Sarasota, Florida, 34243, United States

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St. Petersburg, Florida, 33701, United States

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St. Petersburg, Florida, 33703-2612, United States

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Tallahasse, Florida, 32308, United States

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Tampa, Florida, 33609-4052, United States

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Tampa, Florida, 33614, United States

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Atlanta, Georgia, 30338, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Savannah, Georgia, 31405, United States

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Elkhart, Indiana, 46514, United States

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Des Moines, Iowa, 50309, United States

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Dubuque, Iowa, 52001, United States

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Kansas City, Kansas, 66160, United States

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Crestview Hills, Kentucky, 41017, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40202, United States

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Scarborough, Maine, 04074, United States

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Baltimore, Maryland, United States

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Frederick, Maryland, 21702, United States

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Southfield, Michigan, 48034, United States

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Springfield, Missouri, 65804, United States

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Springfield, Missouri, 65807, United States

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Las Vegas, Nevada, 89052, United States

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Lebanon, New Hampshire, 03766, United States

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Albany, New York, 12208, United States

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The Bronx, New York, 10461, United States

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Asheville, North Carolina, 28801, United States

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Charlotte, North Carolina, 28209, United States

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Winston-Salem, North Carolina, 27103, United States

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Canfield, Ohio, 44406, United States

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Cleveland, Ohio, 44195, United States

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Dayton, Ohio, 45408, United States

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Dayton, Ohio, 45415, United States

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Bend, Oregon, 97701, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97209, United States

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Sellersville, Pennsylvania, 18960, United States

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Upland, Pennsylvania, 19013-3995, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Richmond, Virginia, 23294, United States

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Spokane, Washington, 99204, United States

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Tacoma, Washington, 98405, United States

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Wenatchee, Washington, 98801, United States

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Milwaukee, Wisconsin, 53202, United States

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Buenos Aires, Buenos Aires, 1117, Argentina

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Buenos Aires, Buenos Aires, 1221, Argentina

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Buenos Aires, Buenos Aires, 1419, Argentina

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Buenos Aires, Buenos Aires, 1428, Argentina

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Buenos Aires, Buenos Aires, C1221ACI, Argentina

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Buenos Aires, Buenos Aires F.D., 1209, Argentina

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Buenos Aires, Buenos Aires F.D., 1426, Argentina

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Sydney, New South Wales, 2067, Australia

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Westmead, New South Wales, 2145, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Nedlands, Western Australia, 6009, Australia

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Innsbruck, A-6020, Austria

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Linz, A-4020, Austria

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Sankt Pölten, A-3100, Austria

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Vienna, 1080, Austria

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Antwerp, 2020, Belgium

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Edegem, 2650, Belgium

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Ottignies, 1340, Belgium

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Roeselaere, 8800, Belgium

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Tielt, 8700, Belgium

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Medellín, Antioquia, 000, Colombia

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Bogotá, D.C., 000, Colombia

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Aix-en-Provence, 13100, France

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Angers, 49100, France

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Montbelliard, 25200, France

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Nîmes, 30000, France

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Roanne, 42300, France

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Gera, 0755, Germany

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Hamburg, Germany

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Straubing, 94315, Germany

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Wiesbaden, Germany

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Athens, Attica, 115 26, Greece

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Athens, Attica, 15127, Greece

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Thessaloniki, Macedonia, 546 36, Greece

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Lido di Camaiore, LU, 55043, Italy

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Florence, 50139, Italy

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Grosseto, 58100, Italy

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Imperia, 18100, Italy

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Milan, 20126, Italy

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Napoli, Italy

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Pozzilli, 86077, Italy

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Torino, 10125, Italy

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Mexico City, D.F., Mexico

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Zapopan, Jalisco, C.P. 45200, Mexico

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Mexico City, Mexico City, 14269, Mexico

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Lima, Lima Province, L11, Peru

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Lima, Lima Province, L13, Peru

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Lima, Lima Province, L27, Peru

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Carolina, 00983, Puerto Rico

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Ponce, 00732, Puerto Rico

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Ávila, Avila, 05071, Spain

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Barcelona, Barcelona, 08035, Spain

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Terrassa, Barcelona, 08221, Spain

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Donostia / San Sebastian, Guipuzcoa, 20012, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28040, Spain

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Oviedo, Oviedo, 33006, Spain

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Barcelona, 08003, Spain

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Barcelona, 08036, Spain

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Barcelona, 08041, Spain

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Burgos, 09005, Spain

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Madrid, 28034, Spain

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Zaragoza, 50009, Spain

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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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2003
• First Posted: April 15, 2003
• Study Start: April 1, 2003
• Study Completion: September 1, 2004
• Last Updated: June 7, 2006

Record last verified: 2006-06

Locations

DE (4); BE (5); AR (7); CO (2); GR (3); AU (5); ME (3); PE (3); US (69); IT (8); PR (2); FR (5); ES (14)