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A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Sponsor: Neuron23 Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-01-17
Completion Date
2027-09
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
NEU-411
NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
Placebo
Orally-administered matched placebo
Locations (69)
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
Northwell Health
Great Neck, 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