A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease

Condition(s) targeted: Parkinson's Disease

Intervention: Rasagiline Mesylate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Teva Neuroscience

Official(s) and/or principal investigator(s):
Moshe Kamar, M.D., Study Director, Affiliation: Teva Pharamaceutical Industries

A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline

Official title: A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in UPDRS from baseline

Secondary outcome: Change in UPDRS score from last observed value in the active phase

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Men and women with early idiopathic Parkinson’s disease, whose clinical condition at the time of study enrollment does not require any anti-PD treatment.

2. Subject with diagnosis of PD of less than one and a half years from diagnosis

Exclusion Criteria:

1. Subjects with features that tend to exclude PD as the cause of Parkinsonism:

2. PD patients using any anti-PD medication

3. Unstable medical conditions

4. Pregnant women

Universtiy of Alabama Birmingham, Birmingham, Alabama 35233, United States

University of Alberta - Glenrose Rehab Hospital, Edmonton, Alberta, Canada

University of Calgary Medical Clinicat the Foothills Medical Center, Calgary, Alberta, Canada

University of Arizona - Department of Neurology, Tucson, Arizona 85724, United States

University of British Columbia Hospital, Vancouver, British Columbia, Canada

The Parkinson's & Movement Disorder Institute, Fountain Valley, California 92708, United States

University of California Irvine, Irvine, California 92697, United States

Scripps Clinic, La Jolla, California 92037, United States

Keck/USC School of Medicine, Los Angeles, California 90033, United States

Pacific Neuroscience Medical Group, Oxnard, California 93030, United States

Loma Linda University, Loma Linda, California 92354, United States

The Parkinson's Institute, Sunnyvale, California 94089, United States

Colorado Neurological Institute, Englewood, Colorado 80113, United States

University of Connecticut - Department of Neurology, Farmington, Connecticut 06030, United States

Institute for Neurodegenerative Disorders, New Haven, Connecticut 06510, United States

Associated Neurologists, PC, Danbury, Connecticut 06810, United States

George Washington University Medical Faculty, Washington, District of Columbia 20037, United States

University of Florida College of Medicine - Neurology Dept, Gainesville, Florida 32610, United States

University of South Florida, Tampa, Florida 33606, United States

Parkinson's Disease & Movement Disorders, Boca Raton, Florida 33486, United States

University of Miami, Miami, Florida 33136, United States

Emory University, Atlanta, Georgia 30329, United States

Medical College of Georgia - Department of Neurology, Augusta, Georgia 30912, United States

Instituto Nazionale Neurologico "C. Besta" (7607), Milano, Italy

Instituto de Trastornos Neurologicos GB (7160), Buenos Aires, Argentina

Hospital Espanol (7161), Buenos Aires, Argentina

Hospital Ramos Mejia (7162), Buenos Aires, Argentina

Hospital Frances, Buenos Aires, Argentina

Hospital Universitario Austral (7164), Pilar, Argentina

Medizinische Universitat Innsbruck (7170), Innsbruck, Austria

Donauspital-SMZ Ost (7171), Vienna, Austria

AKh Linz (7172), Linz, Austria

Memory and Motor Skills Disorders, Quebec, Canada

CHU Toulouse-Hopital Purpan-Centre d'Investigation Clinique (7200), Toulouse, France

C.H. du Pays d'Aix-Service de Neurologie (7201), Aix-en-Provence, France

Hopital Gabriel Montpied-Service de Neurologie A (7202), Clermont-Ferrand Cedex, France

Hopital Henri Mondor-Service de Neurologie (7203), Creteil Cedex, France

CHU Lille-Hopital Roger Salengro-Clinique Neurologique A (7204), Lille Cedex, France

Hopital du Haut-Leveque-Service de Neurologie (7205), Pessac, France

CHU de Nantes-Hopital Laennec-Clinique Neurologique (7206), Saint-Herblain, France

UK-SH Kiel (7300), Schittenhelmstr., Germany

Allgemeines Krankenhaus Barmbek (7301), Hamburg, Germany

Universitaet Ulm, Neurologische Klinik im RKU (7302), Ulm, Germany

Praxis Dr. Oehlwein (7303), Gera, Germany

Ruhr-Universitaet im St. Josef-Hospital (7304), Bochum, Germany

Gemeinschaftspraxis Dr. Reifschneider, Unsorg, Dr. Reis (7305), Erbach, Germany

Semmelweis University, Department of Neurology (7400), Budapest, Hungary

Nyiro Gyula Hospital, Department of Neurology (7401), Budapest, Hungary

B-A-Z County Hospital and University Teaching Hospital (7402), Miskolc, Hungary

Javorsky Odon Hospital, Department of Neurology (7403), Vac, Hungary

Kenezy Gyula Hospital and Polyclinic, Department of Neurology (7404), Debrecen, Hungary

Josa Andras County Hospital (7405), Nyiregyhaza, Hungary

Sourasky Medical Center-Neurology Dept. (7500), Tel-Aviv, Israel

Sheba Medical Center (7501), Tel Hashomer, Israel

Hillel Yaffe Medical Center (7502), Hadera, Israel

Asaf Harofeh Medical Center (7503), Zrifin, Israel

Bnei Zion Medical Center (7504), Haifa, Israel

Hadassah Medical Center (7505), Jerusalem, Israel

Rabin Medical Center (Belinson) (7506), Petah Tikva, Israel

Carmel Medical Center (7507), Haifa, Israel

Azienda USL 12 di Viareggio Ospedale Viareggio (7600), Viareggio, Italy

IRCCS Neuromed (7601), Pozzilli, Italy

Fondazione Centro San Raffaele del Monte Tabor (IRCCS) (7602), Milano, Italy

Casa di Cura Villa Margherita (7603), Arcugnano, Italy

Ospedale "La Misericordia" (7604), Grosseto, Italy

Universita degli Studi di Bari, Bari, Italy

Universita Cattolica del Sacro Cuore (7606), Roma, Italy

Ospedale Zona Territoriale N. 12 (7608), San Benedetto del Tronto, Italy

Fondazione "Salvatore Maugeri" (7609), Veruno, Italy

Ospedale Maggiore di Parma (7610), Parma, Italy

Universita "La Sapienza" (7611), Roma, Italy

Ospedale Sane Gerardo Nuovo Unita Operativa di Neurologia (7612), Monza, Italy

A.O. Istituti Clinici di Perfezionamento (7613), Milano, Italy

Amphia Hospital-PD Dept. Neurology (7700), Breda, Netherlands

University Medical Center Groningen-PD dep. Neurology (7701), Groningen, Netherlands

Meander Medical Center PD Dept. Neurology (7702), Amersfoort, Netherlands

Maastricht-PD-Dept. Neurology (7703), Maastricht, Netherlands

Hospital Gooi-Noord-PD Dept. Neurology (7704), Blaricum, Netherlands

Hospital de Santa Maria-Servico de Neurologia (7150), Lisbon, Portugal

Hospitais da Universidade de Coimbra-Servico de Neurologia (7151), Coimbra, Portugal

Hospital Fernando Fonseca-Servico de Neurologia (7152), Amadora, Portugal

CFR University Hospital Constanta (7104), Constanta, Romania

Hospital Clinic i Provincial de Barcelona (7800), Barcelona, Spain

Fundacio de l'Hospital de la Santa Creu i Sant Pau, Neurology (7801), Barcelona, Spain

Hospital General Universitari Vall d'Hebron, Neurology (7802), Barcelona, Spain

Emergency University Hospital Bucharest (7100), Bucharest, Romania

County Clinical Hospital Timisoara (7101), Timisoara, Romania

Clinical Rehabilitation Hospital Cluj (7102), Cluj-Napoca, Romania

County Clinical Hospital Targu Mures (71030, Targu-Mures, Romania

Policlinica Gipuzkoa, Neurology (7803), Barcelona, Spain

Newcastle General Hospital (7900), New Castle Upon Tyne, United Kingdom

Cambourne-Redruth Hospital (7901), Cornwall, United Kingdom

Cambridge Centr for Brain Repair (7902), Cambridge, United Kingdom

Consultants in Neurology, Ltd, Northbrook, Illinois 60062, United States

Rush - Presbyterian St. Luke's Medical Center, Chicago, Illinois 60612, United States

Southern Illinois Univ School of Med, Springfield, Illinois 62702, United States

Northwestern University, Chicago, Illinois 60611, United States

Iowa Health Physicians, Des Moines, Iowa 50309, United States

University of Kansas Medical Center - Landon Center on Aging/Neurology, Kansas City, Kansas 66160, United States

University of Kansas Medical Center - Department of Neurology, Kansas City, Kansas 66160, United States

Port City Neurology, Portland, Maine 04102, United States

St. Boniface Clinic, Winnipeg, Manitoba, Canada

University of Maryland, Baltimore, Maryland 21201, United States

Boston University Medical Center - Department of Neurology, Boston, Massachusetts 02118, United States

Northern Michigan Neurology, Traverse City, Michigan 49684, United States

Michigan State University - Department of Neurology, East Lansing, Michigan 48824, United States

Struther's Parkinson's Center, Golden Valley, Minnesota 55427, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Creighton University, Omaha, Nebraska 68131, United States

UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States

Jacobs Neurological Institute, Buffalo, New York 14203, United States

Mt. Sinai School of Medicine, New York, New York 10029, United States

Raleigh Neurology Associates PA, Raleigh, North Carolina 27607, United States

Duke University, Durham, North Carolina 27705, United States

Dr. David King, Halifax, Nova Scotia, Canada

Medical University of Ohio, Toledo, Ohio 43614, United States

University of Cincinnati, Cincinnati, Ohio 45267, United States

Oklahoma University Neurology, Oklahoma City, Oklahoma 73104, United States

CA Medical Center for Movement Disorders, Markham, Ontario, Canada

London Health Sciences Center - University, London, Ontario, Canada

Parkinson's & Neurodegenerative Disorders Clinic, Ottawa, Ontario, Canada

Toronto Western Hospital - University Health Network, Toronto, Ontario, Canada

Lehigh Valley University, Allentown, Pennsylvania 18103, United States

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States

Pavillon Jeanne Mance, Montreal, Quebec, Canada

NeuroHealth - Department of Neurology, Warwick, Rhode Island 02886, United States

Saskatoon District Health Board Royal University, Saskatoon, Saskatchewan, Canada

Baylor College of Medicine, Houston, Texas 77030, United States

University of Texas - Medical Branch, Department of Neurology, Galveston, Texas 77555, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

University of Texas Houston Medical School, Houston, Texas 77030, United States

University of Vermont, Burlington, Vermont 05401, United States

Virginia Mason Medical Center, Seattle, Washington 98101, United States

Wisconsin Institute for Neurologic and Sleep, Milwaukee, Wisconsin 53233, United States

For more information about Teva Neuroscience

For more information about Parkinson's Disease

Starting date: November 2005
Last updated: November 15, 2006