A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients

PHASE3UnknownINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

July 31, 2019

Study Completion Date

December 31, 2019

Conditions
Parkinson's Disease
Interventions
DRUG

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

DRUG

Sinemet®

Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need

DRUG

Placebo -AP-CD/LD

Placebo for AP-CD/LD capsule

DRUG

Placebo- Sinemet

Placebo for Sinemet tables

Trial Locations (97)

1407

Clinic for Neurology and Sleep Medicine, Sofia

1797

Clinic of Neurological Diseases, Sofia

4002

"University Multiprofile Hospital for Active Treatment Sveti Georgi EAD", Plovdiv

5800

MHAT 'Sv.Pantaleymon - Pleven' OOD, Pleven

9010

"Multiprofile Hospital for Active Treatment Sveta Marina'' EAD", Varna

10016

Fresco Institute for Parkinson's and Movement Disorders, New York

10021

Weill Cornell Medical College of Cornell University, New York

11725

David L. Kreitzman, MD., PC, Commack

12163

Praxis für Neurologie und Psychiatrie, Berlin

17033

Penn State Milton S. Hershey Medical Center, Hershey

18009

Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability, Cherkasy

21100

Ospedale di Circolo e Fondazione Macchi, Varese

22911

Charlottesville Medical Research, Charlottesville

25123

Spedali Civili Di Brescia Azienda Ospedaliera, Brescia

26655

Praxis für Neurologie und Psychiatrie, Westerstede

27100

"IRCCS Neurologico Fondazione C. Mondino", Pavia

28006

Hospital Universitario La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ruber Internacional, Madrid

28222

Hospital Puerta de Hierro Majadahonda, Majadahonda

28702

Hospital Infanta Sofía, San Sebastián de los Reyes

28806

Asheville Neurology Specialists, Asheville

28938

HM Puerta del Sur, Móstoles

29403

Medical University of South Carolina, Charleston

30174

Azienda Unitá Locale Socio Sanitaria 12 Veneziana - Ospedale dell'Angelo, Venezia

32806

Bioclinica Research, Orlando

33486

Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton

33613

Parkinson's Disease and Movement Disorders Center, Tampa

34102

Collier Neurologic Specialists, LLC, Naples

35233

University Alabama Hospital Neurology, Birmingham

36024

Regional Clinical Hospital n.a. N.V. Sklifosovskyi, Poltava

36057

Casa di Cura Villa Margherita, Vicenza

37232

Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences, Nashville

43614

University of Toledo, Toledo

48322

Henry Ford Hospital, West Bloomfield

48334

Quest Research Institute, Farmington Hills

48824

Michigan State University, East Lansing

56126

Azienda Ospedaliero-Universitaria Pisana, Pisa

60126

Ospedali Riuniti di Ancona, Ancona

60612

Rush University Medical Center, Chicago

61068

Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv

63755

Neuroakademie Alzenau GbR, Aschaffenburg

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

66160

The University of Kansas Hospital, Kansas City

69035

"Municipal Institution Zaporizhzhya City Clinical Multidisciplinary Hospital #9", Zaporizhzhya

Municipal Institution 6¿ City Clinical Hospital, Zaporizhzhya

69600

Clinical Hospital #2, Zaporozh’ye

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council, Zaporozh’ye

70021

Ospedale Generale Regionale Francesco Miulli, Acquaviva delle Fonti

74136

The Movement Disorder Clinic of Oklahoma, Tulsa

76021

North Texas Movement Disorders Institute, Bedford

77030

Baylor College of Medicine Department of Neurology, Houston

79010

Lviv City Clinical Hospital, Lviv

80045

University of Colorado Dept. of Neurology, Aurora

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

81675

Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar, München

83103

Neurologicka ambulancia, Euro-Neuro s.r.o., Bratislava

84131

Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona, Salerno

85013

Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center, Phoenix

90033

University of Southern California, Los Angeles

91105

SC3 Research, Pasadena

91335

SC3 Research, Reseda

92354

Loma Linda University Medical Center, Loma Linda

92708

Parkinson's Disease & Movement Disorders Center, Dept of Neu, Fountain Valley

95817

UC Davis Medical Center, Sacramento

98034

Booth Garner Parkinson's Care Center, Kirkland

4941492

Rabin Medical Center, Petah Tikva

06066

Hartford HealthCare, Vernon

02118

Boston University School of Medicine, Boston

03756

Dartmouth Hitchcock Neurology, Lebanon

07902

Atlantic Health System Hospital Corp.-Overlook Hospital, Summit

45267-0525

University of Cincinnati, Cincinnati

01307

Uniklinikum Carl-Gustav Carus an der TU Dresden, Dresden

Unknown

Rambam Medical Center, Haifa

Chaim Sheba Medical Center at Tel Hashomer, Ramat Gan

Dnipropetrovsk medical academy MOH of Ukraine, Dnipro

00163

IRCCS San Raffaele Pisana, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli, Roma

02-777

Centrum Medyczne Damiana Holding, Warsaw

85-021

VITAMED Galaj i Cichomski spólka jawna, Bydgoszcz

42-280

Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED, Częstochowa

40-749

NEURO-CARE Site Management Organization Gabriela Klodowska-Duda, Katowice

40-954

Centrum Medyczne Pratia Katowice I, Katowice

31-505

Krakowska Akademia Neurologii Sp. z o. o., Krakow

90-130

Gabinet Lekarski Prof. Andrzej Bogucki, Lodz

01-868

Centrum Medyczne Pratia Warszawa, Warsaw

01726

KONZÍLIUM s.r.o., Považská Bystrica

01001

NEURON - D.T. s.r.o., Žilina

08028

Hospital Universitari Quirón Dexeus, Barcelona

08035

Hospital Universitari Vall D'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08195

Hospital General de Cataluña, Sant Cugat del Vallès

04114

"State Institution Institute of Gerontology of the AMS of Ukraine", Kyiv

BL9 7TD

Fairfield General Hospital, Bury

NE4 5PL

Newcastle University Clinical Ageing Research, Newcastle upon Tyne

NG7 2UH

Queens Medical Centre Nottingham, University Hospital, Nottingham

ST4 6QG

University Hospitals of North Midlands NHS Trust, Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Intec Pharma Ltd.

INDUSTRY