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Clinical trialNCT04006210Active, not recruitingPhase 3Interventional

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

SponsorNeuroDerm Ltd.Enrollment381Parkinson's Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

103 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria
  • Medical University Innsbruck

    Innsbruck, Austria

Belgium
  • Chu de Tivoli

    La Louvière, Belgium

Czechia
  • Neurologicka Klinika Fakutni Nemocnice Sv. Anny V Brne

    Brno, Czechia

  • Axon Clinical S.R.O.

    Prague, Czechia

France
  • 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

Hungary
  • University of Pecs, Clinical Center

    Pécs, Hungary

Israel
  • Hadassah Medical Center, Ein Kerem

    Jerusalem, Israel

  • Shaare Zedek Medical Center

    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

Italy
  • 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

  • Irccs Santa Lucia Foundation

    Rome, Italy

  • Policlinico Tor Vergata - Uosd Parkinson

    Rome, Italy

Netherlands
  • University of Amsterdam

    Amsterdam, Netherlands

Poland
  • 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

Portugal
  • Hospital Braga

    Braga, Portugal

  • Cns - Campus Neurologico Senior

    Torres Vedras, Portugal

Russia
  • 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

Slovakia
  • Nemocnica Akad. L. Derera

    Bratislava, Slovakia

63 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Oral IR-LD/CDPlacebo for Oral IR-LD/CD
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2019
Primary completion
1 Nov 2022
Completion
28 Feb 2027
Last update posted
21 May 2025
Registered enrollment
381
Registry id
NCT04006210
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.