Fact CheckerSign in

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.
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

Full criteria on ClinicalTrials.gov

Sites (92)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaCompleted
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Coordinator of this site? Confirm its status
La LouviereBelgiumCompleted
Axon Clinical s.r.o.
Coordinator of this site? Confirm its status
Prague 4CzechiaCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital General Universitario de Elche
Coordinator of this site? Confirm its status
ElcheSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitario de la Princesa
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitari General de Catalunya
Coordinator of this site? Confirm its status
Sant Cugat del VallèsSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
BronFranceCompleted
University Hospital Of Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont Ferrand Cedex 1FranceCompleted
Centre Hospitalier Regional De Marseille
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceCompleted
Centre Hospitalier Universitaire De Nimes
Coordinator of this site? Confirm its status
Nimes Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire De Toulouse
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceCompleted
St Georges University Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
King's College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Clinical Ageing Research Unit
Coordinator of this site? Confirm its status
NewcastleUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust
Coordinator of this site? Confirm its status
PlymouthUnited KingdomUnknown status
University of Pecs, Clinical Center
Coordinator of this site? Confirm its status
PécsHungaryUnknown status
Shaare Zedek Medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Hadassah Medical Center - Ein Kerem
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Galilee Medical center- Nahariya
Coordinator of this site? Confirm its status
NahariyaIsraelUnknown status
Rabin Medical Center- Beilinson Hospital
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Chaim Sheba Medical Center
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Irccs San Raffaele Roma S.r.l.
Coordinator of this site? Confirm its status
CassinoItalyActive, not recruiting
Universita' Degli Studi G. D'Annunzio Di Chieti
Coordinator of this site? Confirm its status
Chieti ScaloItalyActive, not recruiting
Azienda USL Toscana Sud Est
Coordinator of this site? Confirm its status
GrossetoItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyActive, not recruiting
Fondazione Santa Lucia IRCCS
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Irccs San Raffaele Roma S.r.l.
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyActive, not recruiting
University of Amsterdam
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Krakowska Akademia Neurologii Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Neuro-Care Sp. z o.o. sp.k.
Coordinator of this site? Confirm its status
KatowicePolandCompleted
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
Coordinator of this site? Confirm its status
LodzPolandCompleted
CCAB Centro Clinico Academico Braga Associacao
Coordinator of this site? Confirm its status
BragaPortugalCompleted
CNS Saude Lda.
Coordinator of this site? Confirm its status
Torres VedrasPortugalCompleted
Kazan State Medical University
Coordinator of this site? Confirm its status
Kazan'RussiaUnknown status
Federal Siberian Scientic Clinical Center of FMBA
Coordinator of this site? Confirm its status
KrasnoyarskRussiaUnknown status
Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
Coordinator of this site? Confirm its status
NovosibirskRussiaUnknown status
The first Saint-Petersburg State Medical University named after IP Pavlov
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Siberian State Medical University
Coordinator of this site? Confirm its status
TomskRussiaUnknown status
University Hospital Bratislava
Coordinator of this site? Confirm its status
BratislavaSlovakiaActive, not recruiting
Clinic "Dopomoga Plus"
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Institute of Gerontolgoy - Parkinsons disease Treatment Centre
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
Coordinator of this site? Confirm its status
PoltavaUkraineUnknown status
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
Coordinator of this site? Confirm its status
VinnytsiaUkraineUnknown status
Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council
Coordinator of this site? Confirm its status
ZaporizhzhyaUkraineUnknown status
Emory University - Brain Health Center
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Visionary Investigators Network
Coordinator of this site? Confirm its status
AventuraUnited StatesUnknown status
Parkinsons Disease And Movement Disorders Center Of Boca Raton
Coordinator of this site? Confirm its status
Boca RatonUnited StatesUnknown status
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of Vermont Medical Center
Coordinator of this site? Confirm its status
BurlingtonUnited StatesUnknown status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Neurology Consultants of Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
NeuroStudies
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
Unity Point Health
Coordinator of this site? Confirm its status
Des MoinesUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Michigan State University
Coordinator of this site? Confirm its status
East LansingUnited StatesUnknown status
Rocky Mountain Movement Disorders Center
Coordinator of this site? Confirm its status
EnglewoodUnited StatesUnknown status
QUEST Research Institute
Coordinator of this site? Confirm its status
Farmington HillsUnited StatesUnknown status
University of Florida, Norman Fixel Institute for Neurological Diseases
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
Hawaii Pacific Neuroscience
Coordinator of this site? Confirm its status
HonoluluUnited StatesUnknown status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
University of Kentucky, Neurology and Movement Disorder
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
Cedar- Sinai Medical Center Department of Neurology
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
University of Wisconsin - Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
Neurology Associates PA
Coordinator of this site? Confirm its status
MaitlandUnited StatesUnknown status
Rutgers, Robert Wood Johnson Medical School
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Oschner Medical Center
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Mount Sinai Medical center Movement Disorders Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Corporal Michael J. Crescenz VA Medical Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Xenoscience
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
SC3 Research - Reseda
Coordinator of this site? Confirm its status
ResedaUnited StatesUnknown status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
USF Parkinson's Disease and Movement Disorders Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Hartford Healthcare Chase Family Movement Disorders Center
Coordinator of this site? Confirm its status
VernonUnited StatesUnknown status
Henry Ford West Bloomfield Hospital
Coordinator of this site? Confirm its status
West BloomfieldUnited StatesUnknown status
Abington Neurological Associates Ltd
Coordinator of this site? Confirm its status
Willow GroveUnited StatesUnknown status
Neurology One
Coordinator of this site? Confirm its status
Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.