Neuron23 Inc.
The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 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. Participants will: • Take NEU-411 or placebo every day for 52 weeks
Parkinson Disease
Parkinson
Idiopathic Parkinson Disease
Early Parkinson Disease (Early PD)
Parkinson Disease, Idiopathic
NEU-411
Placebo
PHASE2
NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study 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 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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 150 participants |
| Masking : | QUADRUPLE |
| Masking Description : | The Sponsor is also masked. |
| Primary Purpose : | TREATMENT |
| Official Title : | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease |
| Actual Study Start Date : | 2025-01-17 |
| Estimated Primary Completion Date : | 2026-09 |
| Estimated Study Completion Date : | 2027-09 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 50 Years to 80 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
RECRUITING
University of Arkansas
Little Rock, Arkansa, United States, 72205
RECRUITING
Neuro-Pain Medical Center
Fresno, California, United States, 93710
RECRUITING
University of California, Irvine
Irvine, California, United States, 92697
NOT YET RECRUITING
University of California, Los Angeles
Los Angeles, California, United States, 90095
NOT YET RECRUITING
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States, 94301
RECRUITING
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
NOT YET RECRUITING
Invication
New Haven, Connecticut, United States, 06510
RECRUITING
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
NOT YET RECRUITING
University of Florida
Gainesville, Florida, United States, 32608
RECRUITING
Neurology One
Orlando, Florida, United States, 32825
RECRUITING
USF Parkinson's & Movement Disorders Clinic
Tampa, Florida, United States, 33613
RECRUITING
Emory University
Atlanta, Georgia, United States, 30329
RECRUITING
Augusta University
Augusta, Georgia, United States, 30912
RECRUITING
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, United States, 60611
RECRUITING
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
RECRUITING
University of Kentucky
Lexington, Kentucky, United States, 40536
NOT YET RECRUITING
University of Maryland
Baltimore, Maryland, United States, 21201
RECRUITING
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
RECRUITING
Quest Research Institute
Farmington Hills, Road cancer, United States, 48334
RECRUITING
Struthers Parkinson Center
Golden Valley, Minnesota, United States, 55427
RECRUITING
Cleveland Clinic
Las Vegas, Nevada, United States, 89106
RECRUITING
Northwell Health
Great Neck, New York, United States, 11021
NOT YET RECRUITING
Icahn School of Medicine at Mount Sinai/Mount Sinai West
New York, New York, United States, 10019
RECRUITING
Columbia University
New York, New York, United States, 10032
RECRUITING
University of Rochester
Rochester, New York, United States, 14618
RECRUITING
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
NOT YET RECRUITING
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, United States, 27607
RECRUITING
The Ohio State University
Columbus, Ohio, United States, 43210
RECRUITING
The Movement Disorder Clinic of Oklahoma
Tulsa, Okholohan, United States, 74136
NOT YET RECRUITING
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
RECRUITING
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
NOT YET RECRUITING
Vanderbilt University
Nashville, Tennessee, United States, 37232
NOT YET RECRUITING
Baylor College of Medicine
Houston, Texas, United States, 77030
NOT YET RECRUITING
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
RECRUITING
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
NOT YET RECRUITING
University of Utah Movement Division
Salt Lake City, Utah, United States, 84108
NOT YET RECRUITING
University of Virginia
Charlottesville, Virginia, United States, 22903
RECRUITING
EvergreenHealth
Kirkland, Washington, United States, 98034
NOT YET RECRUITING
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226