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)

Who is this study for? Patients with Parkinson's disease experiencing motor fluctuations
Status: Active_not_recruiting
Location: See all (101) locations...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• Male and female patients, aged ≥30 years.

• PD diagnosis consistent with the United Kingdom Brain Bank Criteria.

• Modified Hoehn \& Yahr score ≤3 during ON state.

• Average of ≥2.5 hours of OFF time (≥2 hours OFF time every day) during waking hours as confirmed by patient diary over 3 days.

• Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of ≥400mg.

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Xenoscience
Phoenix
California
Cedar- Sinai Medical Center Department of Neurology
Los Angeles
SC3 Research - Reseda
Reseda
University of California San Francisco
San Francisco
Colorado
Rocky Mountain Movement Disorders Center
Englewood
Connecticut
Hartford Healthcare Chase Family Movement Disorders Center
Vernon
Florida
Visionary Investigators Network
Aventura
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville
Neurology Associates PA
Maitland
USF Parkinson's Disease and Movement Disorders Center
Tampa
Neurology One
Winter Park
Georgia
Emory University - Brain Health Center
Atlanta
NeuroStudies
Decatur
Hawaii
Hawaii Pacific Neuroscience
Honolulu
Iowa
Unity Point Health
Des Moines
Illinois
Rush University Medical Center
Chicago
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Kentucky, Neurology and Movement Disorder
Lexington
Louisiana
Oschner Medical Center
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Michigan
Michigan State University
East Lansing
QUEST Research Institute
Farmington Hills
Henry Ford West Bloomfield Hospital
West Bloomfield
North Carolina
Duke University
Durham
New Jersey
Rutgers-Robert Wood Johnson Medical School
New Brunswick
New York
Mount Sinai Medical center Movement Disorders Center
New York
Weill Cornell Medicine
New York
Ohio
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center
Philadelphia
Abington Neurological Associates LTD.
Willow Grove
South Carolina
Medical University of South Carolina
Charleston
Texas
Neurology Consultants of Dallas
Dallas
Virginia
University of Virginia
Charlottesville
Vermont
University of Vermont Medical Center
Burlington
Wisconsin
University of Wisconsin Madison
Madison
Other Locations
Austria
Medical University Innsbruck
Innsbruck
Belgium
CHU de Tivoli
La Louvière
France
Hopital Neurologique
Bron
Hopital Gabriel Montpied
Clermont-ferrand
CHU Nantes-Hopital Laennec
Nantes
CHU de Nice Hpital Pasteur
Nice
Chu Caremeau
Nimes
Hopital Purpan
Toulouse
Hungary
University of Pecs, Clinical Center
Pécs
Israel
Hadassah Medical Center, Ein Kerem
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Galilee Medical center- Nahariya
Nahariya
Rabin Medical Center, Beilinson Hospital
Petah Tikva
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Casa di Cura Villa Margherita
Arcugnano
Centro Ricerca Parkinson San Raffaele Cassino
Cassino
University Chieti CeSI MET Clinical research center-CRC
Chieti
Ospedale di Grosseto, Azienda USL Toscana Sud Est
Grosseto
Istituto Clinico Humanitas - IRCCS
Milano
AOU University of Campania Luigi Vanvitelli
Naples
IRCCS Fondazione C. Mondino
Pavia
IRCCS San Raffaele Pisana
Roma
IRCCS Santa Lucia Foundation
Rome
Policlinico Tor Vergata - UOSD Parkinson
Rome
Netherlands
University of Amsterdam
Amsterdam
Poland
Krakowska Akademia Neurologii Sp. z o. o
Krakow
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
Lodz
Neuro-Care SP z o. o.
Siemianowice Śląskie
Oddział Neurologii ul. L. Kondratowicza 8
Warsaw
Portugal
Hospital Braga
Braga
CNS - Campus Neurologico Senior
Torres Vedras
Russian Federation
Kazan State Medical University
Kazan
Federal Siberian Scientic Clinical Center of FMBA
Krasnoyarsk
Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
Novosibirsk
The first Saint-Petersburg State Medical University named after IP Pavlov
St. Petersburg
Siberian State Medical University
Tomsk
Slovakia
Nemocnica akad. L. Derera
Bratislava
Univerzitna nemocnica L. Pasteura Kosice
Kosice
Spain
Hospital General Universitario de Elche, Edificio principal
Alicante
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital Universitari de la Vall d'Hebron
Barcelona
Hospital Universitari General de Catalunya
Barcelona
Hospital Universitario de Burgos
Burgos
Complejo Hospitalario Ruber Juan Bravo
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Universitario Gregorio Marañón
Madrid
Hospital Universitario Infanta Sofia
Madrid
Hospital Universitario La Princesa
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario central de Asturias
Oviedo
Hospital Universitario Virgen del Rocío, Laboratorio 104.
Sevilla
Hospital Universitario y Politcnico de La Fe
Valencia
Ukraine
Clinic Dopomoga Plus
Kyiv
Institute of Gerontolgoy - Parkinsons disease Treatment Centre
Kyiv
Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
Poltava
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
Vinnytsia
Municipal Non-commercial Institution '' City hospital #9 of Zaporizhzhya City Council
Zaporozhye
United Kingdom
Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
London
King's College hospital
London
St Georges University Hospital
London
Clinical Ageing research Unit
Newcastle
University Hospitals Plymouth NHS Trust
Plymouth
Time Frame
Start Date: 2019-09-30
Completion Date: 2027-02
Participants
Target number of participants: 381
Treatments
Experimental: ND0612 Group
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Active_comparator: IR-LD/CD Group
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Other: Oral IR-LD/CD Adjustment
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
Other: ND0612 Conversion
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
Other: Open-Label Extension
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
Related Therapeutic Areas
Sponsors
Leads: NeuroDerm Ltd.

This content was sourced from clinicaltrials.gov

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