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

April 22, 2026 updated by: Neuron23 Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study and open-label extension (OLE) in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo.

After participants are screened for inclusion in the randomized, placebo-controlled portion of the study, approximately 150 participants will be randomized in a 1:1 allocation to NEU-411 30 mg once per day or placebo for a 52-week treatment period with a safety follow-up visit within 2 weeks after the last treatment visit. Eligible participants may enroll in the OLE and receive treatment for an additional 26 weeks.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Not yet recruiting
        • Rambam Medical Center
        • Contact:
        • Principal Investigator:
          • Ilana Schlesinger, MD, Prof
      • Jerusalem, Israel, 9103102
        • Not yet recruiting
        • Shaare Zedek Medical Center
        • Contact:
        • Principal Investigator:
          • Gilad Yahalom, MD, Prof
      • Ramat Gan, Israel, 5262000
        • Not yet recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Sharon Hassin, MD, Prof
      • Tel Aviv, Israel, 6423906
        • Not yet recruiting
        • Tel Aviv Medical Center
        • Contact:
        • Principal Investigator:
          • Tanya Gurevich, MD, Prof
  • Italy
      • Milan, Italy, 20132
        • Not yet recruiting
        • IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia
        • Contact:
        • Principal Investigator:
          • Massimo Filippi, MD, Prof
      • Naples, Italy, 80138
        • Recruiting
        • Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
        • Contact:
        • Principal Investigator:
          • Alessandro Tessitore, MD, PhD
      • Padua, Italy, 35128
        • Recruiting
        • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica
        • Contact:
        • Principal Investigator:
          • Angelo Antonini, MD, PhD, Prof
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara
        • Contact:
        • Principal Investigator:
          • Roberta Ceravolo, MD, Prof
      • Rome, Italy, 00166
        • Not yet recruiting
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
        • Principal Investigator:
          • Fabrizio Stocchi, MD, PhD
        • Contact:
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policilinico Universitario A Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Anna Rita Bentivoglio, MD, PhD
  • Poland
      • Bydgoszcz, Poland, 85-163
        • Not yet recruiting
        • Centrum Medyczne Neuromed
        • Contact:
        • Principal Investigator:
          • Pawel Lisewski, MD
      • Katowice, Poland, 32-600
        • Not yet recruiting
        • NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski
        • Contact:
        • Principal Investigator:
          • Katarzyna Smilowska, MD, PhD
      • Lublin, Poland, 20-412
        • Not yet recruiting
        • Pro Life Medica Sp. z o. o. ETA Lublin
        • Contact:
        • Principal Investigator:
          • Dominika Tomaka, MD
      • Warsaw, Poland, 02-699
        • Not yet recruiting
        • Insula Badania Sp. Z o.o.
        • Contact:
        • Principal Investigator:
          • Marta Jethon, MD
  • Spain
      • Barakaldo, Spain, 49003
        • Not yet recruiting
        • Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces
        • Contact:
        • Principal Investigator:
          • Juan Carlos Gomez Esteban, MD, PhD
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Jorge Hernandez Vara, MD
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.
        • Contact:
        • Principal Investigator:
          • Alicia Garrido, Pla
      • Madrid, Spain, 28006
        • Recruiting
        • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa
        • Contact:
        • Principal Investigator:
          • Lydia Lopez Manzanares, MD
      • Móstoles, Spain, 28938
        • Recruiting
        • Hospital Universitario HM Puerta del Sur
        • Principal Investigator:
          • Michele Matarazzo, MD
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
        • Contact:
          • Pablo Mir, MD
          • Phone Number: +34 955923039
          • Email: pmir@us.es
        • Principal Investigator:
          • Pablo Mir, MD
    • Donostia
      • San Sebastián, Donostia, Spain, 20014
        • Recruiting
        • Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)
        • Contact:
        • Principal Investigator:
          • Gurutz Linazasoro, MD
  • United Kingdom
    • England
      • London, England, United Kingdom, SW17 0QT
        • Recruiting
        • St George's Hospital, University of London
        • Contact:
        • Principal Investigator:
          • Francesca Morgante, MD
      • London, England, United Kingdom, WC1N 3BG
        • Recruiting
        • University College London Hospitals Nhs Foundation Trust
        • Principal Investigator:
          • Huw Morris, MD, PhD
        • Contact:
      • Newcastle upon Tyne, England, United Kingdom, NE4 5PL
        • Recruiting
        • Clinical Aging Research Unit, Newcastle University
        • Contact:
        • Principal Investigator:
          • Nicola Pavese, MD, PhD, FRCP, FEAN
    • Scotland
      • Dundee, Scotland, United Kingdom, DD19SY
        • Recruiting
        • Ninewells Hospital and Medical School - NHS Tayside
        • Principal Investigator:
          • Esther Sammler, MD
        • Contact:
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Banner Sun Health Research Institute
        • Contact:
        • Principal Investigator:
          • David Shprecher, DO
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas
        • Principal Investigator:
          • Rohit Dhall, MD
        • Contact:
    • California
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro-Pain Medical Center
        • Principal Investigator:
          • Perminder Bhatia, MD
        • Contact:
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Sanaz Attaripour Isfahani, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Principal Investigator:
          • Jeff Bronstein, MD, PhD
      • Murrieta, California, United States, 92562
        • Recruiting
        • Esperanza Clinical
        • Contact:
        • Principal Investigator:
          • Michael Ropacki, PhD
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Parkinson's Research Centers of America - Palo Alto
        • Principal Investigator:
          • Salima Brillman, MD
        • Contact:
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • Nicklesh Thakur, DO
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado - Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Emily Forbes, DO
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
        • Contact:
        • Principal Investigator:
          • Stuart Isaacson, MD, FAAN
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Irene Malaty, MD
        • Contact:
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Neurology One
        • Contact:
        • Principal Investigator:
          • Ramon L Rodriguez, MD, FAAN
      • Tampa, Florida, United States, 33613
        • Recruiting
        • USF Parkinson's & Movement Disorders Clinic
        • Contact:
        • Principal Investigator:
          • Robert Hauser, MD, MBA, FAAN
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Stewart Factor, DO
        • Contact:
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Principal Investigator:
          • John Morgan, MD, PhD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medical Group, Department of Neurology
        • Contact:
        • Principal Investigator:
          • Danielle N Larson, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Rajesh Pahwa, MD
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University Of Kentucky
        • Contact:
        • Principal Investigator:
          • John Slevin, MD, MBA
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Principal Investigator:
          • David Houghton, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • Joseph Savitt, MD, PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Ludy Shih, MD, MMSc
        • Contact:
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
        • Principal Investigator:
          • Aaron Ellenbogen, DO, MPH
        • Contact:
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Recruiting
        • Struthers Parkinson Center
        • Principal Investigator:
          • Sotirios Parashos, MD, PhD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Zoltan Mari, MD
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico
        • Contact:
        • Principal Investigator:
          • Sarah P Richardson, MD, FAAN
    • New York
      • Great Neck, New York, United States, 11021
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Sheng-Han Kuo, MD
        • Contact:
      • New York, New York, United States, 10019
        • Recruiting
        • Icahn School of Medicine at Mount Sinai/Mount Sinai West
        • Contact:
        • Principal Investigator:
          • Joohi Jimenez-Shahed, MD
      • Rochester, New York, United States, 14618
        • Recruiting
        • University of Rochester
        • Contact:
        • Principal Investigator:
          • Christopher Tarolli, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina - Chapel Hill
        • Contact:
        • Principal Investigator:
          • Daniel Roque, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Ariane Park, MD, MPH
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • The Movement Disorder Clinic of Oklahoma
        • Contact:
        • Principal Investigator:
          • Kevin Klos, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University (OHSU)
        • Contact:
        • Principal Investigator:
          • Joseph Quinn, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Tsao-Wei Liang, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Christine Cooper, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • David Charles, MD
    • Texas
      • Dallas, Texas, United States, 75243
        • Not yet recruiting
        • Neurology Consultants Of Dallas PA
        • Contact:
        • Principal Investigator:
          • Nirav Pavasia, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Arjun Tarakad, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Principal Investigator:
          • Raja Mehanna, MD
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Central Texas Neurology Consultants
        • Principal Investigator:
          • Elizabeth Peckham, DO
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Movement Division
        • Principal Investigator:
          • Paolo Moretti, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Binit Shah, MD, FAAN
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • EvergreenHealth
        • Contact:
        • Principal Investigator:
          • Pinky Agarwal, MD, FAAN
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Inland Northwest Research
        • Principal Investigator:
          • Jason Aldred, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Karen Blindauer, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEU-411
Orally-administered NEU-411
Drug: NEU-411
NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
Placebo Comparator: Placebo
Orally-administered matching placebo
Other: Placebo
Orally-administered matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo
Time Frame: From enrollment to the end of treatment at 52 weeks
From enrollment to the end of treatment at 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
Time Frame: From enrollment to the end of study at 54 weeks
From enrollment to the end of study at 54 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: 52 weeks
Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuron23 Inc.

Collaborators

Roche Diagnostic Ltd.
Qiagen Manchester Limited

Investigators

  • Principal Investigator: Fatta B Nahab, MD, FAAN FANA, Neuron23 Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU-411-PD201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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