420
Participants
Start Date
March 31, 2016
Primary Completion Date
July 31, 2019
Study Completion Date
December 31, 2019
Accordion Pill™ Carbidopa/Levodopa
AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day
Sinemet®
Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
Placebo -AP-CD/LD
Placebo for AP-CD/LD capsule
Placebo- Sinemet
Placebo for Sinemet tables
Clinic for Neurology and Sleep Medicine, Sofia
Clinic of Neurological Diseases, Sofia
"University Multiprofile Hospital for Active Treatment Sveti Georgi EAD", Plovdiv
MHAT 'Sv.Pantaleymon - Pleven' OOD, Pleven
"Multiprofile Hospital for Active Treatment Sveta Marina'' EAD", Varna
Fresco Institute for Parkinson's and Movement Disorders, New York
Weill Cornell Medical College of Cornell University, New York
David L. Kreitzman, MD., PC, Commack
Praxis für Neurologie und Psychiatrie, Berlin
Penn State Milton S. Hershey Medical Center, Hershey
Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability, Cherkasy
Ospedale di Circolo e Fondazione Macchi, Varese
Charlottesville Medical Research, Charlottesville
Spedali Civili Di Brescia Azienda Ospedaliera, Brescia
Praxis für Neurologie und Psychiatrie, Westerstede
"IRCCS Neurologico Fondazione C. Mondino", Pavia
Hospital Universitario La Princesa, Madrid
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Ruber Internacional, Madrid
Hospital Puerta de Hierro Majadahonda, Majadahonda
Hospital Infanta Sofía, San Sebastián de los Reyes
Asheville Neurology Specialists, Asheville
HM Puerta del Sur, Móstoles
Medical University of South Carolina, Charleston
Azienda Unitá Locale Socio Sanitaria 12 Veneziana - Ospedale dell'Angelo, Venezia
Bioclinica Research, Orlando
Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton
Parkinson's Disease and Movement Disorders Center, Tampa
Collier Neurologic Specialists, LLC, Naples
University Alabama Hospital Neurology, Birmingham
Regional Clinical Hospital n.a. N.V. Sklifosovskyi, Poltava
Casa di Cura Villa Margherita, Vicenza
Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences, Nashville
University of Toledo, Toledo
Henry Ford Hospital, West Bloomfield
Quest Research Institute, Farmington Hills
Michigan State University, East Lansing
Azienda Ospedaliero-Universitaria Pisana, Pisa
Ospedali Riuniti di Ancona, Ancona
Rush University Medical Center, Chicago
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv
Neuroakademie Alzenau GbR, Aschaffenburg
Tel Aviv Sourasky Medical Center, Tel Aviv
The University of Kansas Hospital, Kansas City
"Municipal Institution Zaporizhzhya City Clinical Multidisciplinary Hospital #9", Zaporizhzhya
Municipal Institution 6¿ City Clinical Hospital, Zaporizhzhya
Clinical Hospital #2, Zaporozh’ye
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council, Zaporozh’ye
Ospedale Generale Regionale Francesco Miulli, Acquaviva delle Fonti
The Movement Disorder Clinic of Oklahoma, Tulsa
North Texas Movement Disorders Institute, Bedford
Baylor College of Medicine Department of Neurology, Houston
Lviv City Clinical Hospital, Lviv
University of Colorado Dept. of Neurology, Aurora
Azienda Ospedaliera Universitaria Federico II, Napoli
Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar, München
Neurologicka ambulancia, Euro-Neuro s.r.o., Bratislava
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona, Salerno
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center, Phoenix
University of Southern California, Los Angeles
SC3 Research, Pasadena
SC3 Research, Reseda
Loma Linda University Medical Center, Loma Linda
Parkinson's Disease & Movement Disorders Center, Dept of Neu, Fountain Valley
UC Davis Medical Center, Sacramento
Booth Garner Parkinson's Care Center, Kirkland
Rabin Medical Center, Petah Tikva
Hartford HealthCare, Vernon
Boston University School of Medicine, Boston
Dartmouth Hitchcock Neurology, Lebanon
Atlantic Health System Hospital Corp.-Overlook Hospital, Summit
University of Cincinnati, Cincinnati
Uniklinikum Carl-Gustav Carus an der TU Dresden, Dresden
Rambam Medical Center, Haifa
Chaim Sheba Medical Center at Tel Hashomer, Ramat Gan
Dnipropetrovsk medical academy MOH of Ukraine, Dnipro
IRCCS San Raffaele Pisana, Roma
Fondazione Policlinico Universitario Agostino Gemelli, Roma
Centrum Medyczne Damiana Holding, Warsaw
VITAMED Galaj i Cichomski spólka jawna, Bydgoszcz
Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED, Częstochowa
NEURO-CARE Site Management Organization Gabriela Klodowska-Duda, Katowice
Centrum Medyczne Pratia Katowice I, Katowice
Krakowska Akademia Neurologii Sp. z o. o., Krakow
Gabinet Lekarski Prof. Andrzej Bogucki, Lodz
Centrum Medyczne Pratia Warszawa, Warsaw
KONZÍLIUM s.r.o., Považská Bystrica
NEURON - D.T. s.r.o., Žilina
Hospital Universitari Quirón Dexeus, Barcelona
Hospital Universitari Vall D'Hebron, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Hospital General de Cataluña, Sant Cugat del Vallès
"State Institution Institute of Gerontology of the AMS of Ukraine", Kyiv
Fairfield General Hospital, Bury
Newcastle University Clinical Ageing Research, Newcastle upon Tyne
Queens Medical Centre Nottingham, University Hospital, Nottingham
University Hospitals of North Midlands NHS Trust, Stoke-on-Trent
Lead Sponsor
Intec Pharma Ltd.
INDUSTRY