Actively Recruiting
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Led by Neuron23 Inc. · Updated on 2026-04-24
150
Participants Needed
70
Research Sites
136 weeks
Total Duration
On this page
Sponsors
N
Neuron23 Inc.
Lead Sponsor
Q
Qiagen Manchester Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 40-80 years at time of screening, inclusive
- Diagnosis of clinically established or clinically probable Parkinson's Disease
- LRRK2-driven Parkinson's Disease confirmed by investigational companion diagnostic genetic test
- Modified Hoehn and Yahr stage of 1 to 2.5
You will not qualify if you...
- Secondary or atypical parkinsonian syndromes
- Uncontrolled diabetes mellitus with hemoglobin A1c greater than 8%
- Other significant medical conditions as determined by medical history, examination, or clinical investigations at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 locations
1
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Actively Recruiting
2
University of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Neuro-Pain Medical Center
Fresno, California, United States, 93710
Actively Recruiting
4
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
5
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
6
Esperanza Clinical
Murrieta, California, United States, 92562
Actively Recruiting
7
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States, 94301
Actively Recruiting
8
Sutter Neuroscience Institute
Sacramento, California, United States, 95816
Actively Recruiting
9
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
10
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Actively Recruiting
11
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
12
Neurology One
Orlando, Florida, United States, 32825
Actively Recruiting
13
USF Parkinson's & Movement Disorders Clinic
Tampa, Florida, United States, 33613
Actively Recruiting
14
Emory University
Atlanta, Georgia, United States, 30329
Actively Recruiting
15
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
16
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, United States, 60611
Actively Recruiting
17
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
18
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
19
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
20
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
21
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
22
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
23
Struthers Parkinson Center
Golden Valley, Minnesota, United States, 55427
Actively Recruiting
24
Cleveland Clinic
Las Vegas, Nevada, United States, 89106
Actively Recruiting
25
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
26
Northwell Health
Great Neck, New York, United States, 11021
Actively Recruiting
27
Icahn School of Medicine at Mount Sinai/Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
28
Columbia University
New York, New York, United States, 10032
Actively Recruiting
29
University of Rochester
Rochester, New York, United States, 14618
Actively Recruiting
30
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
31
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
32
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
33
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
34
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
35
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
36
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
37
Neurology Consultants of Dallas PA
Dallas, Texas, United States, 75243
Not Yet Recruiting
38
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
39
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
40
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
Actively Recruiting
41
University of Utah Movement Division
Salt Lake City, Utah, United States, 84108
Actively Recruiting
42
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
43
EvergreenHealth
Kirkland, Washington, United States, 98034
Actively Recruiting
44
Inland Northwest Research
Spokane, Washington, United States, 99202
Actively Recruiting
45
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
46
Rambam Medical Center
Haifa, Israel, 3109601
Not Yet Recruiting
47
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Not Yet Recruiting
48
Sheba Medical Center
Ramat Gan, Israel, 5262000
Not Yet Recruiting
49
Tel Aviv Medical Center
Tel Aviv, Israel, 6423906
Not Yet Recruiting
50
IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia
Milan, Italy, 20132
Not Yet Recruiting
51
Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria
Naples, Italy, 80138
Actively Recruiting
52
Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica
Padua, Italy, 35128
Actively Recruiting
53
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara
Pisa, Italy, 56126
Not Yet Recruiting
54
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
Rome, Italy, 00166
Not Yet Recruiting
55
Fondazione Policilinico Universitario A Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
56
Centrum Medyczne Neuromed
Bydgoszcz, Poland, 85-163
Not Yet Recruiting
57
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski
Katowice, Poland, 32-600
Not Yet Recruiting
58
Pro Life Medica Sp. z o. o. ETA Lublin
Lublin, Poland, 20-412
Not Yet Recruiting
59
Insula Badania Sp. Z o.o.
Warsaw, Poland, 02-699
Not Yet Recruiting
60
Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)
San Sebastián, Donostia, Spain, 20014
Actively Recruiting
61
Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces
Barakaldo, Spain, 49003
Not Yet Recruiting
62
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
63
Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.
Barcelona, Spain, 08036
Actively Recruiting
64
Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
65
Hospital Universitario HM Puerta del Sur
Móstoles, Spain, 28938
Actively Recruiting
66
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Spain, 41013
Actively Recruiting
67
St George's Hospital, University of London
London, England, United Kingdom, SW17 0QT
Actively Recruiting
68
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom, WC1N 3BG
Actively Recruiting
69
Clinical Aging Research Unit, Newcastle University
Newcastle upon Tyne, England, United Kingdom, NE4 5PL
Actively Recruiting
70
Ninewells Hospital and Medical School - NHS Tayside
Dundee, Scotland, United Kingdom, DD19SY
Actively Recruiting
Research Team
F
Fatta B Nahab, MD, FAAN, FANA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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