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

NCT06680830 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NEU-411-PD201
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 70

Brief Summary

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.

Conditions

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

Keywords

Early PD; Parkinsons; Parkinsons Disease; Idiopathic Parkinsons Disease; leucine-rich repeat kinase 2; PD; NEULARK; LRRK2; PARK8; de novo Parkinsons disease; Parkinson's disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo

  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

  From enrollment to the end of study at 54 weeks

Secondary Outcomes (1)

• Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  52 weeks

Study Arms (2)

NEU-411

EXPERIMENTAL

Orally-administered NEU-411

Drug: NEU-411

Placebo

PLACEBO COMPARATOR

Orally-administered matching placebo

Other: Placebo

Interventions

NEU-411 DRUG

NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity

NEU-411

Placebo OTHER

Orally-administered matched placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Secondary or atypical parkinsonian syndromes
• Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
• Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)

Sponsors & Collaborators

• Neuron23 Inc.: lead
• Qiagen Manchester Limited: collaborator
• Roche Diagnostic Ltd.: collaborator

Study Sites (70)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

RECRUITING

University of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

Neuro-Pain Medical Center

Fresno, California, 93710, United States

RECRUITING

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Esperanza Clinical

Murrieta, California, 92562, United States

RECRUITING

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States

RECRUITING

Sutter Neuroscience Institute

Sacramento, California, 95816, United States

RECRUITING

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Neurology One

Orlando, Florida, 32825, United States

RECRUITING

USF Parkinson's & Movement Disorders Clinic

Tampa, Florida, 33613, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, 60611, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Struthers Parkinson Center

Golden Valley, Minnesota, 55427, United States

RECRUITING

Cleveland Clinic

Las Vegas, Nevada, 89106, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87106, United States

RECRUITING

Northwell Health

Great Neck, New York, 11021, United States

RECRUITING

Icahn School of Medicine at Mount Sinai/Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

University of Rochester

Rochester, New York, 14618, United States

RECRUITING

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

Neurology Consultants of Dallas PA

Dallas, Texas, 75243, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

RECRUITING

University of Utah Movement Division

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

EvergreenHealth

Kirkland, Washington, 98034, United States

RECRUITING

Inland Northwest Research

Spokane, Washington, 99202, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

NOT YET RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, 5262000, Israel

NOT YET RECRUITING

Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

NOT YET RECRUITING

IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia

Milan, 20132, Italy

NOT YET RECRUITING

Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria

Naples, 80138, Italy

RECRUITING

Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica

Padua, 35128, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara

Pisa, 56126, Italy

NOT YET RECRUITING

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

Rome, 00166, Italy

NOT YET RECRUITING

Fondazione Policilinico Universitario A Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Centrum Medyczne Neuromed

Bydgoszcz, 85-163, Poland

NOT YET RECRUITING

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski

Katowice, 32-600, Poland

NOT YET RECRUITING

Pro Life Medica Sp. z o. o. ETA Lublin

Lublin, 20-412, Poland

NOT YET RECRUITING

Insula Badania Sp. Z o.o.

Warsaw, 02-699, Poland

NOT YET RECRUITING

Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)

San Sebastián, Donostia, 20014, Spain

RECRUITING

Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces

Barakaldo, 49003, Spain

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.

Barcelona, 08036, Spain

RECRUITING

Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Universitario HM Puerta del Sur

Móstoles, 28938, Spain

RECRUITING

Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

Seville, 41013, Spain

RECRUITING

St George's Hospital, University of London

London, England, SW17 0QT, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, England, WC1N 3BG, United Kingdom

RECRUITING

Clinical Aging Research Unit, Newcastle University

Newcastle upon Tyne, England, NE4 5PL, United Kingdom

RECRUITING

Ninewells Hospital and Medical School - NHS Tayside

Dundee, Scotland, DD19SY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Fatta B Nahab, MD, FAAN FANA

  Neuron23 Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatta B Nahab, MD, FAAN, FANA

CONTACT

650-228-2527; clinicaltrials@neuron23.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor is also masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7); GB (4); IL (4); IT (6); US (45); PL (4)