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
NCT ID: NCT04006210
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
381 participants
INTERVENTIONAL
2019-09-30
2027-02-28
Brief Summary
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Subjects can continue to an optional open-label extension period.
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Detailed Description
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This study is comprised of 6 periods:
1. a Screening Period;
2. an open-label oral IR-LD/CD Adjustment Period;
3. an open-label ND0612 Conversion Period;
4. a randomized DBDD active-controlled Maintenance Period;
5. an optional open-label Treatment Extension; and
6. a Safety Follow-up Period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) 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
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.
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
Oral IR-LD/CD Adjustment
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
ND0612 Conversion
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Open-Label Extension
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
3. Modified Hoehn \& Yahr score ≤3 during "ON" state.
4. 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.
5. 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.
Exclusion Criteria
2. Severe disabling dyskinesias, based on Investigator's discretion.
3. Previous neurosurgery for PD.
4. Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
6. Previous participation in ND0612 studies.
7. History of significant skin conditions or disorders.
30 Years
ALL
No
Sponsors
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NeuroDerm Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Alberto J Espay, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati OH, USA
Olivier Rascol, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Toulouse University Hospital, France
Locations
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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
Countries
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References
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Espay AJ, Stocchi F, Pahwa R, Albanese A, Ellenbogen A, Ferreira JJ, Giladi N, Gurevich T, Hassin-Baer S, Hernandez-Vara J, Isaacson SH, Kieburtz K, LeWitt PA, Lopez-Manzanares L, Olanow CW, Poewe W, Sarva H, Yardeni T, Adar L, Salin L, Lopes N, Sasson N, Case R, Rascol O; BouNDless Study Group. Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial. Lancet Neurol. 2024 May;23(5):465-476. doi: 10.1016/S1474-4422(24)00052-8. Epub 2024 Mar 15.
Related Links
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European Union Clinical Trials Register
Other Identifiers
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ND0612-317
Identifier Type: -
Identifier Source: org_study_id
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