Parkinson's disease is a major neurodegenerative disorder in which there is a progressive
loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of
dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a
precursor of DA that crosses the blood brain barrier, and also to the use of selective
inhibitors of MAO B, the major DA metabolising enzyme in man.
This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi
national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p. o. q. a.m.)
versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects
with early idiopathic Parkinson's Disease.
The principal efficacy measure, i. e., change in mean value of UPDRS - Section III total
score from baseline to endpoint, was chosen based on regulatory guidance and prior use in
other trials in similar populations.
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
Hospital Español, Buenos Aires, Argentina
Instituto de Neurociencias Buenos Aires S.A., Buenos Aires, Argentina
Clinica IMECO, Capital Federal, Argentina
Hospital Italiano de Buenos Aires, Capital Federal, Argentina
Instituto de Investigaciones Neurológicas Raul Carrea FLENI, Capital Federal, Argentina
Instituto Frenopatico S.A., Capital Federal, Argentina
Instituto Medico Congreso, Ciudad Autonoma de Bs. As., Argentina
Instituto Argentino de Investigacion Neurologica SRL, Ciudad Autonoma de, Argentina
Instituto INEBA, Ciudad Autónoma de Bs. As., Argentina
Hospital Privado Centro Médico de Córdoba, Cordoba, Argentina
Hospital Universitario Austral, Pilar, Argentina
Hospital das Clinicas da UFPR, Curitiba, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
Centro Pediatrico Professor Hosanna de Oliveira, Salvador, Brazil
Hospital Universitario Professor Edgard Santos - UFBA, Salvador, Brazil
CCB Medical Institute - Ministry of Interior, Sofia, Bulgaria
First MHAT - Sofia AD, Sofia, Bulgaria
MHAT Tokuda Hospital Sofia AD, Sofia, Bulgaria
Shatcvd - Nch Ead, Sofia, Bulgaria
SHATNP 'Sv. Naum' EAD, Sofia, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL' EAD, Sofia, Bulgaria
Kingston General Hospital, Kingston, Canada
Centre For Movement Disorders, Markham, Canada
Parkinson's and Neurodegenerative Disorders Clinic, Ottawa, Canada
Toronto Western Hospital - University Health Network, Toronto, Canada
Hospital Barros Luco Trudeau, Santiago, Chile
Hospital Base Valdivia, Valdivia, Chile
Clinica Ciudad del Mar, Viña del Mar, Chile
Centro de Investigaciones del Sistema Nervioso Limitada, Bogota, Colombia
Fundación Clínica Abood Shaio, Bogotá, Colombia
Instituto del Corazón, Bucaramanga, Colombia
Clinical Hospital Osijek, Osijek, Croatia
Clinical Hospital Center Rijeka, Rijeka, Croatia
Clinical Hospital "Sestre Milosrdnice", Zagreb, Croatia
Clinical Hospital Centre Zagreb, Zagreb, Croatia
Fakultni nemocnice Brno, Brno, Czech Republic
Privatni neurologicka ambulance, Hradec Kralove, Czech Republic
Poliklinika Modry pavilon, Ostrava, Czech Republic
Clintrials.r.o., Praha 10, Czech Republic
VFN Praha, Praha 2, Czech Republic
Itä-Suomen yliopisto Kuopion kampus, Kuopio, Finland
Etelä-Karjalan keskussairaala, Lappeenranta, Finland
ODL Terveys Oy, Oulu, Finland
Charité Universitaetsmedizin Berlin - Campus Charité Mitte, Berlin, Germany
Ehret Reinhard, Berlin, Germany
St. Josef-Hospital, Berlin, Germany
Eberhard-Karls-Universitaet, Tuebingen, Germany
Universitaetsklinikum Ulm, Ulm, Germany
Krishna Institute of Medical Sciences, Hyderabad, India
Nizam's Institute of Medical Sciences, Hyderabad, India
Mallikatta Neuro and Research Centre, Mangalore`, India
T.N. Medical College & B.Y.L. Nair Hospital, Mumbai, India
Brain & Mind Institute, Nagpur, India
All India Institute of Medical Sciences (AIIMS), New Delhi, India
Poona Hospital & Research Center, Pune, India
Andhra Medical College, Vishakapatnam, India
AO Universitaria Policlinico di Catania, Catania, Italy
Fondazione Università Gabriele D'Annunzio, Chieti, Italy
Ospedale Versilia, Lido di Camaiore, Italy
Fondazione San Raffaele del Monte Tabor, Milano, Italy
Istituti Clinici di Perfezionamento, Milano, Italy
Università degli Studi "Federico II", Napoli, Italy
Azienda Ospedaliera Universitaria di Parma, Parma, Italy
IRCCS S. Raffaele Pisana, Roma, Italy
Ospedale San Giovanni Battista Ordine di Malta, Roma, Italy
Policlinico Tor Vergata, Roma, Italy
Instituto Nacional de Neurologia, Colonia La Fama, Mexico
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Mexico
Medical Sur, Mexico, Mexico
Instituto de Información de Investigación en Salud Mental, Monterrey, Mexico
Hospital Alberto Sabogal Sologuren, Callao, Peru
Clinica Anglo Americana, Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen, Lima, Peru
Pomorskie Centr.Traumatologii WSS im.M.Kopernika, Gdansk, Poland
Hospital de Santa Maria, Lisboa, Portugal
MU Dr. Beata Dupejova Neurologicka ambulancia s.r.o, Banska Bystrica, Slovakia
FNsP Bratislava pracovisko Kramare, Bratislava, Slovakia
Poliklinika Tehelna, Bratislava, Slovakia
Vseobecna nemocnica s poliklinikou Levoca a.s., Levoca, Slovakia
Fakultna nemocnica Trnava, Trnava, Slovakia
Nestatne zdravotnicke zariadenie, Zilina, Slovakia
Constantiaberg Medi-Clinic, Cape Town, South Africa
Groote Schuur Hospital, Cape Town, South Africa
St. Augustine's Medical Mews, Durban, South Africa
Willows Medical Centre, Pretoria, South Africa
H Clinic i Provincial, Barcelona, Spain
H de la Santa Creu i Sant Pau, Barcelona, Spain
H Mutua de Terrassa, Barcelona, Spain
Fundacion H. Alcorcon, Madrid, Spain
Fundacion Jimenez Diaz, Madrid, Spain
Policlinica Guipuzcoa, San Sebastian, Spain
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Neurological Institute, Phoenix, Arizona, United States
Pacific Neuroscience Medical Group, Oxnard, California, United States
San Francisco Clinical Research Center, San Francisco, California, United States
Parkinson's Institute, Sunnyvale, California, United States
Institute for Neurodegenerative Disorders, New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorder Center, Boca Raton, Florida, United States
Neurologic Consultants P.A., Ft Lauderdale, Florida, United States
University Of Florida, Gainesville, Florida, United States
Parkinson's Disease Treatment Center of SW Florida, Port Charlotte, Florida, United States
Neurology Clinical Research Inc., Sunrise, Florida, United States
University Of South Florida Medical Center, Tampa, Florida, United States
Sandton Clinic, Johannesburg, Gauteng, South Africa
Emory University, Atlanta, Georgia, United States
Medical College of Georgia, Augusta, Georgia, United States
Columbus Research Institute, Columbus, Georgia, United States
Northwestern University PD and Movement Disorders Center, Chicago, Illinois, United States
Dr CC Coetzee Inc, Durban, KZ-Natal, South Africa
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Boston University School of Medicine, Boston, Massachusetts, United States
Parkinson's Disease and Movement Disorders Center of Albany, Albany, New York, United States
North Shore Medical Center, Manhasset, New York, United States
Columbia University Medical Center, New York, New York, United States
New York University, New York, New York, United States
The Neurological Institute, Charlotte, North Carolina, United States
Duke University Health Systems, Druham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Neurology Specialists, Dayton, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Lankenau Hospital, Wynnewood, Pennsylvania, United States
Dynamik Research Inc., Pointe-Claire, Quebec H9R 3J1, Canada
Butler Hospital, Providence, Rhode Island, United States
Baylor College of Medicine, Houston, Texas, United States