NCT06680830RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
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)
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- 17 Jan 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Neuron23 Inc.
- Diseases
- Parkinson disease
- NCT number
- NCT06680830
- EU CT number
- 2024-515448-22-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 17 Jan 2025 to the primary completion date, Dec 2027
- 76 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Secondary or atypical parkinsonian syndromes
- 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.
Lab values
- Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
Who the study is looking for
- Aged 40-80 years at time of screening, inclusive
- Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
- LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
- Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Biocruces Bizkaia Health Research Center Institute Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Policlinica Gipuzkoa S.A. Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario HM Puerta del Sur Coordinator of this site? Confirm its status | Móstoles | Spain | Recruiting |
| Hospital Universitario Virgen del Rocío Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Ninewells Hospital and Medical School - NHS Tayside Coordinator of this site? Confirm its status | Dundee | United Kingdom | Recruiting |
| London North West University Healthcare NHS Trust - Northwick Park Hospital Coordinator of this site? Confirm its status | Harrow | United Kingdom | Not yet recruiting |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Panthera Enfield Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| St George's Hospital, University of London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Clinical Aging Research Unit, Newcastle University Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel Aviv Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| ASST Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| AOU Policlinico-San Marco Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Recruiting |
| IRCCS - Ospedale San Raffaele Coordinator of this site? Confirm its status | Milano | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Universita Degli Studi Di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Ospedale Santa Chiara Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. Coordinator of this site? Confirm its status | Pozzilli | Italy | Recruiting |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Pro Life Medica Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Insula Badania Sp. Z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| University of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Parkinson's Disease and Movement Disorders Center of Boca Raton Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Northwestern Medical Group, Department of Neurology Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Neurology Consultants of Dallas, PA Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| Neuro-Pain Medical Center Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Struthers Parkinson Center Coordinator of this site? Confirm its status | Golden Valley | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| EvergreenHealth Coordinator of this site? Confirm its status | Kirkland | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| University of Arkansas Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Northwell Health Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Esperanza Clinical Coordinator of this site? Confirm its status | Murrieta | United States | Completed |
| Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai/Mount Sinai West Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Neurology One Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Parkinson?s Research Centers of America ? Palo Alto Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health & Science University (OHSU) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Central Texas Neurology Consultants Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Sutter Neuroscience Institute Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of Utah Movement Division Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Inland Northwest Research Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Banner Sun Health Research Institute Coordinator of this site? Confirm its status | Sun City | United States | Recruiting |
| USF Parkinson's & Movement Disorders Clinic Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| The Movement Disorder Clinic of Oklahoma Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.