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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Neuron23 Inc. • ClinicalTrials.gov ID: NCT06680830

Registry updated: 2026-10-02
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Description

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.

Interventions

  • NEU-411 (Drug)
    NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
  • Placebo (Other)
    Orally-administered matched placebo

Eligibility criteria

Inclusion Criteria: 1. Aged 40-80 years at time of screening, inclusive 2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD) 3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx) 4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5 Exclusion Criteria: 1. Secondary or atypical parkinsonian syndromes 2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8% 3. 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.

Conditions

Parkinson Disease Parkinson Idiopathic Parkinson Disease Early Parkinson Disease (Early PD) Parkinson Disease, Idiopathic

Locations

  • Banner Sun Health Research Institute — Sun City, Arizona, United States
  • University of Arkansas — Little Rock, Arkansas, United States
  • Neuro-Pain Medical Center — Fresno, California, United States
  • University of California, Irvine — Irvine, California, United States
  • University of California, Los Angeles — Los Angeles, California, United States
  • Esperanza Clinical — Murrieta, California, United States
  • Parkinson's Research Centers of America - Palo Alto — Palo Alto, California, United States
  • Sutter Neuroscience Institute — Sacramento, California, United States
  • University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States
  • Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
  • University of Florida — Gainesville, Florida, United States
  • Neurology One — Orlando, Florida, United States
  • USF Parkinson's & Movement Disorders Clinic — Tampa, Florida, United States
  • Emory University — Atlanta, Georgia, United States
  • Augusta University — Augusta, Georgia, United States
  • Northwestern Medical Group, Department of Neurology — Chicago, Illinois, United States
  • University of Kansas Medical Center — Kansas City, Kansas, United States
  • University of Kentucky — Lexington, Kentucky, United States
  • Ochsner Clinic Foundation — New Orleans, Louisiana, United States
  • University of Maryland — Baltimore, Maryland, United States
  • Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
  • Quest Research Institute — Farmington Hills, Michigan, United States
  • Struthers Parkinson Center — Golden Valley, Minnesota, United States
  • Cleveland Clinic — Las Vegas, Nevada, United States
  • University of New Mexico — Albuquerque, New Mexico, United States
  • Northwell Health — Manhasset, New York, United States
  • Icahn School of Medicine at Mount Sinai/Mount Sinai West — New York, New York, United States
  • Columbia University — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
  • The Ohio State University — Columbus, Ohio, United States
  • The Movement Disorder Clinic of Oklahoma — Tulsa, Oklahoma, United States
  • Oregon Health & Science University (OHSU) — Portland, Oregon, United States
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Vanderbilt University — Nashville, Tennessee, United States
  • Neurology Consultants of Dallas PA — Dallas, Texas, United States
  • Baylor College of Medicine — Houston, Texas, United States
  • The University of Texas Health Science Center at Houston — Houston, Texas, United States
  • Central Texas Neurology Consultants — Round Rock, Texas, United States
  • University of Utah Movement Division — Salt Lake City, Utah, United States
  • University of Virginia — Charlottesville, Virginia, United States
  • EvergreenHealth — Kirkland, Washington, United States
  • Inland Northwest Research — Spokane, Washington, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Rambam Medical Center — Haifa, Israel
  • Shaare Zedek Medical Center — Jerusalem, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Tel Aviv Medical Center — Tel Aviv, Israel
  • IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia — Milan, Italy
  • Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria — Naples, Italy
  • Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica — Padua, Italy
  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara — Pisa, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana — Rome, Italy
  • Fondazione Policilinico Universitario A Gemelli IRCCS — Rome, Italy
  • Centrum Medyczne Neuromed — Bydgoszcz, Poland
  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski — Katowice, Poland
  • Pro Life Medica Sp. z o. o. ETA Lublin — Lublin, Poland
  • Insula Badania Sp. Z o.o. — Warsaw, Poland
  • Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP) — San Sebastián, Donostia, Spain
  • Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces — Barakaldo, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A. — Barcelona, Spain
  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa — Madrid, Spain
  • Hospital Universitario HM Puerta del Sur — Móstoles, Spain
  • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS) — Seville, Spain
  • St George's Hospital, University of London — London, England, United Kingdom
  • University College London Hospitals NHS Foundation Trust — London, England, United Kingdom
  • Clinical Aging Research Unit, Newcastle University — Newcastle upon Tyne, England, United Kingdom
  • Ninewells Hospital and Medical School - NHS Tayside — Dundee, Scotland, United Kingdom
  • London North West University Healthcare NHS Trust - Northwick Park Hospital — Harrow, United Kingdom
  • Panthera Enfield — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record