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NCT06680830RecruitingPhase 2

A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
150 (estimated)
First submitted
5 Nov 2024
Start date
17 Jan 2025
Primary completion date
Dec 2027
Lead sponsor
Neuron23 Inc.
NCT number
NCT06680830
EU CT number
2024-515448-22-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 150
  • From 17 Jan 2025 to the primary completion date, Dec 2027
  • 76 sites in 6 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.

Other illness

  • Secondary or atypical parkinsonian syndromes
  • Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)
    • Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.

Lab values

  • Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%

Who the study is looking for

  • Aged 40-80 years at time of screening, inclusive
  • Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
  • LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
  • Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (76)

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

SiteCityCountrySite status
Biocruces Bizkaia Health Research Center Institute
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BarakaldoSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Policlinica Gipuzkoa S.A.
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DonostiaSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital Universitario HM Puerta del Sur
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MóstolesSpainRecruiting
Hospital Universitario Virgen del Rocío
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SevillaSpainRecruiting
Ninewells Hospital and Medical School - NHS Tayside
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DundeeUnited KingdomRecruiting
London North West University Healthcare NHS Trust - Northwick Park Hospital
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HarrowUnited KingdomNot yet recruiting
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomRecruiting
Panthera Enfield
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LondonUnited KingdomNot yet recruiting
St George's Hospital, University of London
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LondonUnited KingdomRecruiting
Clinical Aging Research Unit, Newcastle University
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Newcastle upon TyneUnited KingdomRecruiting
Rambam Medical Center
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HaifaIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Tel Aviv Medical Center
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Tel AvivIsraelRecruiting
ASST Spedali Civili di Brescia
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BresciaItalyRecruiting
AOU Policlinico-San Marco
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CataniaItalyRecruiting
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyRecruiting
IRCCS - Ospedale San Raffaele
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MilanoItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Universita Degli Studi Di Padova
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PadovaItalyRecruiting
Ospedale Santa Chiara
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PisaItalyRecruiting
Istituto Neurologico Mediterraneo Neuromed S.p.A.
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PozzilliItalyRecruiting
Irccs San Raffaele Roma S.r.l.
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandRecruiting
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
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KatowicePolandRecruiting
Pro Life Medica Sp. z o.o.
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LublinPolandRecruiting
Insula Badania Sp. Z o.o.
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WarsawPolandRecruiting
University of New Mexico
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AlbuquerqueUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Augusta University
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AugustaUnited StatesRecruiting
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
University of Maryland
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BaltimoreUnited StatesRecruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton
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Boca RatonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
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BostonUnited StatesRecruiting
University of North Carolina, Chapel Hill
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
University of Virginia
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CharlottesvilleUnited StatesRecruiting
Northwestern Medical Group, Department of Neurology
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ChicagoUnited StatesRecruiting
The Ohio State University
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ColumbusUnited StatesRecruiting
Neurology Consultants of Dallas, PA
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DallasUnited StatesRecruiting
QUEST Research Institute
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Farmington HillsUnited StatesRecruiting
Neuro-Pain Medical Center
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FresnoUnited StatesRecruiting
University of Florida
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GainesvilleUnited StatesRecruiting
Struthers Parkinson Center
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Golden ValleyUnited StatesRecruiting
Baylor College of Medicine
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HoustonUnited StatesRecruiting
The University of Texas Health Science Center at Houston
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HoustonUnited StatesRecruiting
University of California, Irvine
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IrvineUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
EvergreenHealth
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KirklandUnited StatesRecruiting
Cleveland Clinic
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Las VegasUnited StatesRecruiting
University of Kentucky
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LexingtonUnited StatesRecruiting
University of Arkansas
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Little RockUnited StatesRecruiting
University of California, Los Angeles
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Los AngelesUnited StatesRecruiting
Northwell Health
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ManhassetUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Esperanza Clinical
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MurrietaUnited StatesCompleted
Vanderbilt University
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NashvilleUnited StatesRecruiting
Ochsner Clinic Foundation
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New OrleansUnited StatesRecruiting
Columbia University
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New YorkUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai/Mount Sinai West
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New YorkUnited StatesRecruiting
Neurology One
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OrlandoUnited StatesRecruiting
Parkinson?s Research Centers of America ? Palo Alto
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Palo AltoUnited StatesRecruiting
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesRecruiting
Oregon Health & Science University (OHSU)
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PortlandUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Central Texas Neurology Consultants
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Round RockUnited StatesRecruiting
Sutter Neuroscience Institute
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SacramentoUnited StatesRecruiting
University of Utah Movement Division
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Salt Lake CityUnited StatesRecruiting
Inland Northwest Research
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SpokaneUnited StatesRecruiting
Banner Sun Health Research Institute
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Sun CityUnited StatesRecruiting
USF Parkinson's & Movement Disorders Clinic
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TampaUnited StatesRecruiting
The Movement Disorder Clinic of Oklahoma
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TulsaUnited StatesRecruiting

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