Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

November 1, 2022

Study Completion Date

February 28, 2027

Conditions
Parkinson's Disease
Interventions
COMBINATION_PRODUCT

ND0612 Solution for SC infusion

Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump

COMBINATION_PRODUCT

Placebo for SC infusion

Placebo solution administered SC via infusion pump

DRUG

Oral IR-LD/CD

Encapsulated LD/CD 100mg/25mg

DRUG

Placebo for Oral IR-LD/CD

Encapsulated Placebo for LD/CD 100mg/25mg

Trial Locations (103)

179

IRCCS Santa Lucia Foundation, Rome

1105

University of Amsterdam, Amsterdam

4114

Institute of Gerontolgoy - Parkinsons disease Treatment Centre, Kyiv

6002

CHU de Nice Hpital Pasteur, Nice

6020

Medical University Innsbruck, Innsbruck

7100

CHU de Tivoli, La Louvière

7623

University of Pecs, Clinical Center, Pécs

10021

Weill Cornell Medicine, New York

10029

Mount Sinai Medical center Movement Disorders Center, New York

20089

Istituto Clinico Humanitas - IRCCS, Milan

21005

Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital, Vinnytsia

22100

Galilee Medical center- Nahariya, Nahariya

27100

IRCCS Fondazione C. Mondino, Pavia

27705

Duke University, Durham

28006

Complejo Hospitalario Ruber Juan Bravo, Madrid

Hospital Universitario La Princesa, Madrid

28007

Hospital Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28702

Hospital Universitario Infanta Sofia, Madrid

29425

Medical University of South Carolina, Charleston

30033

NeuroStudies, Decatur

30329

Emory University - Brain Health Center, Atlanta

31059

Hopital Purpan, Toulouse

32608

University of Florida Norman Fixel Institute for Neurological Diseases, Gainesville

32792

Neurology One, Winter Park

33011

Hospital Universitario central de Asturias, Oviedo

33180

Visionary Investigators Network, Aventura

33613

USF Parkinson's Disease and Movement Disorders Center, Tampa

36011

Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy, Poltava

36057

Casa di Cura Villa Margherita, Arcugnano

41013

Hospital Universitario Virgen del Rocío, Laboratorio 104., Seville

44195

Cleveland Clinic, Cleveland

44800

CHU Nantes-Hopital Laennec, Nantes

45219

University of Cincinnati, Cincinnati

46026

Hospital Universitario y Politcnico de La Fe, Valencia

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48824

Michigan State University, East Lansing

49100

Rabin Medical Center, Beilinson Hospital, Petah Tikva

50309

Unity Point Health, Des Moines

58100

Ospedale di Grosseto, Azienda USL Toscana Sud Est, Grosseto

60612

Rush University Medical Center, Chicago

63000

Hopital Gabriel Montpied, Clermont-Ferrand

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65691

Neurologicka klinika Fakutni nemocnice sv. Anny v Brne, Brno

66100

University Chieti CeSI MET Clinical research center-CRC, Chieti

66160

University of Kansas Medical Center, Kansas City

69065

"Municipal Non-commercial Institution '' City hospital #9 of Zaporizhzhya City Council", Zaporizhzhya

69677

Hopital Neurologique, Bron

70121

Oschner Medical Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

75243

Neurology Consultants of Dallas, Dallas

80113

Rocky Mountain Movement Disorders Center, Englewood

80138

"AOU University of Campania Luigi Vanvitelli", Naples

85004

Xenoscience, Phoenix

91335

SC3 Research - Reseda, Reseda

94115

University of California San Francisco, San Francisco

96817

Hawaii Pacific Neuroscience, Honolulu

197022

The first Saint-Petersburg State Medical University named after IP Pavlov, Saint Petersburg

420012

Kazan State Medical University, Kazan'

630054

Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34, Novosibirsk

634050

Siberian State Medical University, Tomsk

660037

Federal Siberian Scientic Clinical Center of FMBA, Krasnoyarsk

5265601

Chaim Sheba Medical Center, Ramat Gan

9103102

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah Medical Center, Ein Kerem, Jerusalem

90048 -1804

Cedar- Sinai Medical Center Department of Neurology, Los Angeles

06066

Hartford Healthcare Chase Family Movement Disorders Center, Vernon

33486-2359

Parkinsons Disease and Movement Disorders Center of Boca Raton, Boca Raton

32751-4723

Neurology Associates PA, Maitland

40536-0284

University of Kentucky, Neurology and Movement Disorder, Lexington

02215

Beth Israel Deaconess Medical Center, Boston

48334-2980

QUEST Research Institute, Farmington Hills

08901

Rutgers-Robert Wood Johnson Medical School, New Brunswick

19101-4511

Corporal Michael J. Crescenz VA Medical Center, Philadelphia

19090-1749

Abington Neurological Associates LTD., Willow Grove

05401

University of Vermont Medical Center, Burlington

22908-0816

University of Virginia, Charlottesville

53705-2281

University of Wisconsin Madison, Madison

150 00

Axon Clinical s.r.o., Prague

GARD 30000

Chu Caremeau, Nîmes

03043

Centro Ricerca Parkinson San Raffaele Cassino, Cassino

RM 163

IRCCS San Raffaele Pisana, Roma

00133

Policlinico Tor Vergata - UOSD Parkinson, Rome

31-505

Krakowska Akademia Neurologii Sp. z o. o, Krakow

90-640

NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki, Lodz

41-100

Neuro-Care SP z o. o., Siemianowice Śląskie

03-242

Oddział Neurologii ul. L. Kondratowicza 8, Warsaw

4710-243

Hospital Braga, Braga

256-280

CNS - Campus Neurologico Senior, Torres Vedras

833 05

Nemocnica akad. L. Derera, Bratislava

04166

Univerzitna nemocnica L. Pasteura Kosice, Košice

03203

Hospital General Universitario de Elche, Edificio principal, Alicante

08035

Hospital Universitari de la Vall d'Hebron, Barcelona

08041

Hospital de La Santa Creu I Sant Pau, Barcelona

08195

Hospital Universitari General de Catalunya, Barcelona

09006

Hospital Universitario de Burgos, Burgos

04111

"Clinic Dopomoga Plus", Kyiv

SE5 9RT

King's College hospital, London

SW17 0QT

St Georges University Hospital, London

W6 8RF

Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust, London

NE4 5PL

Clinical Ageing research Unit, Newcastle

PL6 5FP

University Hospitals Plymouth NHS Trust, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NeuroDerm Ltd.

INDUSTRY

NCT04006210 - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations | Biotech Hunter | Biotech Hunter