Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

PHASE3CompletedINTERVENTIONAL
Enrollment

549

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

January 31, 2012

Study Completion Date

March 31, 2012

Conditions
Idiopathic Parkinson's Disease
Interventions
DRUG

Safinimide 50-100 mg/day

Safinamide, (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate, is an a-aminoamide derivative

DRUG

Matching Placebo

Matching Placebo

Trial Locations (121)

Unknown

University of Alabama at Birmingham, Birmingham

Barrow Neurological Institute, Phoenix

Mayo Clinic Scottsdale, Scottsdale

San Francisco Clinical Research Center, San Francisco

Parkinson's Institute, Sunnyvale

Institute for Neurodegenerative Disorders, New Haven

Parkinson's Disease and Movement Disorder Center, Boca Raton

Neurologic Consultants P.A., Fort Lauderdale

University of Florida, Gainesville

Parkinson's Disease Treatment Center of SW Florida, Port Charlotte

Neurology Clinical Research Inc., Sunrise

University Of South Florida Medical Center, Tampa

Wesley Woods Geriatric Center, Atlanta

Columbus Research Institute, Columbus

Northwestern University PD and Movement Disorders Center, Chicago

Rush University Medical Center, Chicago

University of Kansas Medical Center, Kansas City

University of Maryland Medical Center, Baltimore

Boston University School of Medicine, Boston

Quest Research Institute, Bingham Farms

Parkinson's Disease and Movement Disorder Center, Albany

North Shore Medical Center, Manhasset

Neurological Institute of New York, New York

The Neurological Institute, Charlotte

Duke Movement Disorders Clinic, Durham

Pennsylvania Hospital, Philadelphia

Vanderbilt University Medical Center, Nashville

Baylor College of Medicine, Houston

Concord Repatriation General Hospital, Concord

Central Coast Neuroscience Research, East Gosford

Univ.Klinik Graz, Graz

Univ.Klinik Innsbruck, Innsbruck

Cliniques Universitaires Saint-Luc, Brussels

U.Z Antwerpen, Edegem

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

ZNA Hoge Beuken, Hoboken

Heilig Hart Roeselare - Campus westlaan, Roeselare

AZ Sint-Augustinus, Wilrijk

Research Site, Halifax

Parkinson's and Neurodegenerative Disorders Clinic, Ottawa

University Health Network -Toronto Western Hosp., Toronto

Dynamic Clinical Research Group, Pointe-Claire

King David, Halifax

Kingston General Hospital, Kingston

Tartu University Hospital, Tartu

CHU Hopital Gabriel Montpied, Clermont-Ferrand

CHU La Miletrie, Miletrie Poitiers

CHU Nantes Hôpital Laennec - CIC Neurologie, Nantes

CHU de Nimes, Hopital Caremeau, Nîmes

CIC-Hospital Purpan, Pavillon Riser Toulouse

Kliniken Beelitz GmbH, Beelitz-Heilstätten

Charité Campus Virchow Universitaetsmedizin Berlin, Berlin

Ehret Reinhard, Berlin

St. Joseph-Krankenhaus Berlin-Weißensee, Berlin

Universitaetsklinikum Goettingen, Göttingen

Arzneimittelforschung Leipzig GmbH, Leipzig

Philipps-Universitaet Marburg, Marburg

Praxis Dipl med Bodenschatz, Mittweida

Neurologisches Krankenhaus Muenchen, München

Eberhard-Karls-Universität, Tübingen

Universitätsklinikum, Ulm

Deutsche Klinik fuer Diagnostik, Wiesbaden

Clinexpert Kereskedelmi es Szolgaltato Kft., Budapest

Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp., Budapest

Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály, Budapest

Nyiro Gyula Korhaz, Budapest

Semmelweis Egyetem, Budapest

SOTE Neurlogia, Budapest

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc

DE OEC Neurologiai Klinika, Móricz

Peterfy S. Utcai Korhaz, Peterfy Sandor

Sopron Medical Egeszsegugyi Szolgaltato Kft., Sopron

BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke, Szentpetri

Nizam's Institute of Medical Sciences, Hyderabad

King George Hospital, Visakhapatnam

M. S. Ramaiah Medical College and Hospital, Bangalore

All India Institute of Medical Sciences (AIIMS), New Delhi

Mallikatta Neuro and Research Centre, Mangalore

BYL Nair Hospital ¬ TN Medical College, Mumbai Mahara

Brain & Mind Institute, Nagpur

Christian Medical College Hospital, Vellore

Barzilai Medical Center, Ashkelon

Rambam Health Care Campus, Haifa

Rabin Medical Center, Petah Tikva

Sheba Medical Center, Ramat Gan

Sieff Government Hospital, Safed

Sourasky Medical Center, Tel Aviv

Hospital Pulau Pinang, George Town

University of Malaya Medical Center, Kuala Lumpur

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

Auckland City Hospital, Aucklan

Van der Veer Institute for Parkinson's & Brain Research, Christchurch

Waikato Hospital, Hamilton

MU Dr.Beata Dupejová neurologicka ambulancia s.r.o, Banská Bystrica

Poliklinika Tehelna, Bratislava

Vseobecna nemocnica s poliklinikou Levoca, Levoča

Fakultna nemocnica Trnava Interna klinika, Slovak Republic

Nestatne zdravotnicke zariadenie Neurologicka ambulancia, Slovak Republic

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University College of Medicine, Seoul

Policlinica Guipuzcoa, Donostia / San Sebastian

Fundacion Hospital de Alcorcon, Madrid

Fundacion Jimenez Diaz, Madrid

HU Carlos Haya, Málaga

Inselspital Bern, Bern

Hopitaux Universitaires de Geneve - Hug, Geneva

Chang-Hua Christian Hospital, Chang-hua

Kaohsiung Veterans General Hospital, Kaohsiung City

Shin Kong Wu Ho-Su Memorial Hospital, Taipei

King Chulalongkorn Memorial Hospital, Bangkok

Phramongkutklao Hospital, Bangkok

Rajavithi Hospital, Bangkok

Lampang Hospital, Lampang

Sappasithiprasong Hospital, Ubonratchathani

Fylde Coast Hospital, Blackpool

Addenbrookes NHS Trust, Cambridge

Southern General Hospital, Glasgow

Royal Free Hospital, London

Clinical Ageing Research Unit, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Newron Pharmaceuticals SPA

INDUSTRY

NCT00627640 - Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa | Biotech Hunter | Biotech Hunter