A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
NCT ID: NCT06680830
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-01-17
2027-09-30
Brief Summary
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Participants will:
• Take NEU-411 or placebo every day for 52 weeks
Detailed Description
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After participants are screened for inclusion in the study, approximately 150 participants will be randomized in a 1:1 allocation ratio to NEU-411 30 mg once per day or placebo for a 52-week treatment period. A safety follow-up visit will occur 2 weeks after the last treatment visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NEU-411
Orally-administered NEU-411
NEU-411
NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
Placebo
Orally-administered matching placebo
Placebo
Orally-administered matched placebo
Interventions
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NEU-411
NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
Placebo
Orally-administered matched placebo
Eligibility Criteria
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Inclusion Criteria
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
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)
40 Years
80 Years
ALL
No
Sponsors
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Qiagen Manchester Limited
UNKNOWN
Roche Diagnostic Ltd.
INDUSTRY
Neuron23 Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fatta B Nahab, MD, FAAN FANA
Role: PRINCIPAL_INVESTIGATOR
Neuron23 Inc.
Locations
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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
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States
Invicro
New Haven, Connecticut, 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
Velocity Clinical Research at Raleigh Neurology
Raleigh, 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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia
Milan, , Italy
Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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Serena Lowery
Role: primary
Erin Hatcher
Role: primary
Mirian Payo
Role: primary
Sophia Dungo
Role: primary
Diane Yang
Role: primary
Esperanza Clinical
Role: primary
Leeana Bade
Role: primary
Emily Forbes, DO
Role: primary
Stephanie Roman
Role: primary
Karla Arias
Role: primary
Camille Swartz
Role: primary
Carem Acosta
Role: primary
Erica Botting
Role: primary
Brian Sperin
Role: primary
Buff Farrow
Role: primary
Camryn Butze
Role: primary
Emily Jackson
Role: primary
Corisa Logan
Role: primary
Anna Leonard-Leumas
Role: primary
Victoria Davis
Role: primary
Hannah Babcock
Role: primary
Nancy Virdi
Role: primary
Carrie Weaver
Role: primary
Liliana Dumitrescu
Role: primary
Noureddin Elayan
Role: primary
Ricardo Renvill
Role: primary
Columbia Movement Disorders Research
Role: primary
Amy Chesire
Role: primary
Jessica Ferrall
Role: primary
Tracey Pate
Role: primary
Katherine Ambrogi
Role: primary
Elise Gibson
Role: primary
Emily Leonard
Role: primary
Brian Urbani
Role: primary
Robin Bulgarino
Role: primary
Haley Kling
Role: primary
Christina Howell
Role: primary
Rory Mahabir
Role: primary
Brittany Duncan
Role: primary
Koni Lopez
Role: primary
Kendra Fowler
Role: primary
Lauren Miller
Role: primary
Gowri Rajendran
Role: primary
Taylor Aderman
Role: primary
Daniela Capilupo
Role: primary
Teresa Del Santo
Role: primary
Angelo Antonini
Role: primary
Pierangela Riani
Role: primary
Miriam Casali
Role: primary
Flavia Torlizzi
Role: primary
Beata Lisewska
Role: primary
Katarzyna Smilowska
Role: primary
Dominika Tomaka, MD
Role: primary
Marta Jethon
Role: primary
Gurutz Linazasoro, MD
Role: primary
Naiara Azcue
Role: primary
Jorge Hernandez Vara, MD
Role: primary
Alicia Garrido, Pla
Role: primary
Lydia Lopez Manzanares
Role: primary
Patricia Vicente
Role: primary
Pablo Mir, MD
Role: primary
Francesca Morgante, MD
Role: primary
Ellie Clook
Role: primary
Nicola Pavese, MD, PhD, FRCP, FEAN
Role: primary
Justine Hudson
Role: primary
Other Identifiers
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NEU-411-PD201
Identifier Type: -
Identifier Source: org_study_id