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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
Sponsor: NeuroDerm Ltd.
Summary
This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period.
Official title: A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel-group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
381
Start Date
2019-09-30
Completion Date
2027-02
Last Updated
2025-05-21
Healthy Volunteers
No
Conditions
Interventions
ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Placebo for SC infusion
Placebo solution administered SC via infusion pump
Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Placebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Locations (103)
Xenoscience
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Cedar- Sinai Medical Center Department of Neurology
Los Angeles, California, United States
SC3 Research - Reseda
Reseda, California, United States
University of California San Francisco
San Francisco, California, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States
Hartford Healthcare Chase Family Movement Disorders Center
Vernon, Connecticut, United States
Visionary Investigators Network
Aventura, Florida, United States
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Neurology One
Winter Park, Florida, United States
Emory University - Brain Health Center
Atlanta, Georgia, United States
NeuroStudies
Decatur, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
Unity Point Health
Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky, Neurology and Movement Disorder
Lexington, Kentucky, United States
Oschner Medical Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Weill Cornell Medicine
New York, New York, United States
Mount Sinai Medical center Movement Disorders Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, United States
Abington Neurological Associates LTD.
Willow Grove, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Neurology Consultants of Dallas
Dallas, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Medical University Innsbruck
Innsbruck, Austria
CHU de Tivoli
La Louvière, Belgium
Neurologicka klinika Fakutni nemocnice sv. Anny v Brne
Brno, Czechia
Axon Clinical s.r.o.
Prague, Czechia
Hopital Neurologique
Bron, France
Hopital Gabriel Montpied
Clermont-Ferrand, France
CHU Nantes-Hopital Laennec
Nantes, France
CHU de Nice Hpital Pasteur
Nice, France
Chu Caremeau
Nîmes, France
Hopital Purpan
Toulouse, France
University of Pecs, Clinical Center
Pécs, Hungary
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center, Ein Kerem
Jerusalem, Israel
Galilee Medical center- Nahariya
Nahariya, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Casa di Cura Villa Margherita
Arcugnano, Italy
Centro Ricerca Parkinson San Raffaele Cassino
Cassino, Italy
University Chieti CeSI MET Clinical research center-CRC
Chieti, Italy
Ospedale di Grosseto, Azienda USL Toscana Sud Est
Grosseto, Italy
Istituto Clinico Humanitas - IRCCS
Milan, Italy
AOU University of Campania "Luigi Vanvitelli"
Naples, Italy
IRCCS Fondazione C. Mondino
Pavia, Italy
IRCCS San Raffaele Pisana
Roma, Italy
Policlinico Tor Vergata - UOSD Parkinson
Rome, Italy
IRCCS Santa Lucia Foundation
Rome, Italy
University of Amsterdam
Amsterdam, Netherlands
Krakowska Akademia Neurologii Sp. z o. o
Krakow, Poland
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
Lodz, Poland
Neuro-Care SP z o. o.
Siemianowice Śląskie, Poland
Oddział Neurologii ul. L. Kondratowicza 8
Warsaw, Poland
Hospital Braga
Braga, Portugal
CNS - Campus Neurologico Senior
Torres Vedras, Portugal
Kazan State Medical University
Kazan', Russia
Federal Siberian Scientic Clinical Center of FMBA
Krasnoyarsk, Russia
Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
Novosibirsk, Russia
The first Saint-Petersburg State Medical University named after IP Pavlov
Saint Petersburg, Russia
Siberian State Medical University
Tomsk, Russia
Nemocnica akad. L. Derera
Bratislava, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario de Elche, Edificio principal
Alicante, Spain
Hospital Universitari de la Vall d'Hebron
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitari General de Catalunya
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Infanta Sofia
Madrid, Spain
Hospital Universitario Virgen del Rocío, Laboratorio 104.
Seville, Spain
Hospital Universitario y Politcnico de La Fe
Valencia, Spain
Clinic "Dopomoga Plus"
Kyiv, Ukraine
Institute of Gerontolgoy - Parkinsons disease Treatment Centre
Kyiv, Ukraine
Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
Poltava, Ukraine
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
Vinnytsia, Ukraine
Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council
Zaporizhzhya, Ukraine
King's College hospital
London, United Kingdom
St Georges University Hospital
London, United Kingdom
Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
London, United Kingdom
Clinical Ageing research Unit
Newcastle, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom