NCT04006210Active, not recruitingPhase 3
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
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)
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 381 (actual)
- First submitted
- 30 Jun 2019
- Start date
- 30 Sept 2019
- Primary completion date
- 1 Nov 2022
- Lead sponsor
- NeuroDerm Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT04006210
- EU CT number
- 2024-511940-20-00
- EudraCT number
- 2018-004156-37
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 381
- From 30 Sept 2019 to the primary completion date, 1 Nov 2022
- 92 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous neurosurgery for PD.
- Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
- Previous participation in ND0612 studies.
Other illness
- History of significant skin conditions or disorders.
Other
- Atypical or secondary parkinsonism.
- Severe disabling dyskinesias, based on Investigator's discretion.
- Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
Who the study is looking for
- 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.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (92)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Completed |
| Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes Coordinator of this site? Confirm its status | La Louviere | Belgium | Completed |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| St Georges University Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Clinical Ageing Research Unit Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| University Hospitals Plymouth NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| University of Pecs, Clinical Center Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Hadassah Medical Center - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Galilee Medical center- Nahariya Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Rabin Medical Center- Beilinson Hospital Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Cassino | Italy | Active, not recruiting |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Active, not recruiting |
| Azienda USL Toscana Sud Est Coordinator of this site? Confirm its status | Grosseto | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Fondazione Santa Lucia IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| University of Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Neuro-Care Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Completed |
| CNS Saude Lda. Coordinator of this site? Confirm its status | Torres Vedras | Portugal | Completed |
| Kazan State Medical University Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Federal Siberian Scientic Clinical Center of FMBA Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Unknown status |
| Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34 Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| The first Saint-Petersburg State Medical University named after IP Pavlov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Siberian State Medical University Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Active, not recruiting |
| Clinic "Dopomoga Plus" Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Institute of Gerontolgoy - Parkinsons disease Treatment Centre Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy Coordinator of this site? Confirm its status | Poltava | Ukraine | Unknown status |
| Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
| Emory University - Brain Health Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Visionary Investigators Network Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Parkinsons Disease And Movement Disorders Center Of Boca Raton Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Neurology Consultants of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| NeuroStudies Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Unity Point Health Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Michigan State University Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
| Rocky Mountain Movement Disorders Center Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| University of Florida, Norman Fixel Institute for Neurological Diseases Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Hawaii Pacific Neuroscience Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kentucky, Neurology and Movement Disorder Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Cedar- Sinai Medical Center Department of Neurology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Neurology Associates PA Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Rutgers, Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Oschner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Mount Sinai Medical center Movement Disorders Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Corporal Michael J. Crescenz VA Medical Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Xenoscience Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| SC3 Research - Reseda Coordinator of this site? Confirm its status | Reseda | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| USF Parkinson's Disease and Movement Disorders Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Hartford Healthcare Chase Family Movement Disorders Center Coordinator of this site? Confirm its status | Vernon | United States | Unknown status |
| Henry Ford West Bloomfield Hospital Coordinator of this site? Confirm its status | West Bloomfield | United States | Unknown status |
| Abington Neurological Associates Ltd Coordinator of this site? Confirm its status | Willow Grove | United States | Unknown status |
| Neurology One Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.