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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
RecruitingPhase 2
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)
Who can join
Ages 40 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria:
1. Aged 40-80 years at time of screening, inclusive
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:
1. Secondary or atypical parkinsonian syndromes
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)
Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.
About the study
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.
What is being tested
- NEU-411 (drug)
- Placebo (other)
Sponsor: Neuron23 Inc. · Participants: 150 · Started: Jan 17, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06680830
Locations in the U.S.
| Arizona | Banner Sun Health Research Institute, Sun City |
| Arkansas | University of Arkansas, Little Rock |
| California | Neuro-Pain Medical Center, Fresno
University of California, Irvine, Irvine
University of California, Los Angeles, Los Angeles
Esperanza Clinical, Murrieta
Parkinson's Research Centers of America - Palo Alto, Palo Alto
Sutter Neuroscience Institute, Sacramento |
| Colorado | University of Colorado - Anschutz Medical Campus, Aurora |
| Florida | Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton
University of Florida, Gainesville
Neurology One, Orlando
USF Parkinson's & Movement Disorders Clinic, Tampa |
| Georgia | Emory University, Atlanta
Augusta University, Augusta |
| Illinois | Northwestern Medical Group, Department of Neurology, Chicago |
| Kansas | University of Kansas Medical Center, Kansas City |
| Kentucky | University of Kentucky, Lexington |
| Louisiana | Ochsner Clinic Foundation, New Orleans |
| Maryland | University of Maryland, Baltimore |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston |
| Michigan | Quest Research Institute, Farmington Hills |
| Minnesota | Struthers Parkinson Center, Golden Valley |
| Nevada | Cleveland Clinic, Las Vegas |
| New Mexico | University of New Mexico, Albuquerque |
| New York | Northwell Health, Manhasset
Columbia University, New York
Icahn School of Medicine at Mount Sinai/Mount Sinai West, New York
University of Rochester, Rochester |
| North Carolina | University of North Carolina - Chapel Hill, Chapel Hill |
| Ohio | The Ohio State University, Columbus |
| Oklahoma | The Movement Disorder Clinic of Oklahoma, Tulsa |
| Oregon | Oregon Health & Science University (OHSU), Portland |
| Pennsylvania | Thomas Jefferson University Hospital, Philadelphia |
| South Carolina | Medical University of South Carolina, Charleston |
| Tennessee | Vanderbilt University, Nashville |
| Texas | Neurology Consultants of Dallas PA, Dallas
Baylor College of Medicine, Houston
The University of Texas Health Science Center at Houston, Houston
Central Texas Neurology Consultants, Round Rock |
| Utah | University of Utah Movement Division, Salt Lake City |
| Virginia | University of Virginia, Charlottesville |
| Washington | EvergreenHealth, Kirkland
Inland Northwest Research, Spokane |
| Wisconsin | Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.