A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Recruiting · NCT06680830 · Interventional (participants receive a specific treatment) · Lead sponsor: Neuron23 Inc.
View the official record on ClinicalTrials.gov →Interventions studied
NEU-411Placebo
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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Secondary or atypical parkinsonian syndromes
- Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
- 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.
Where it is running
60 locations listed across 29 US states.
- 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
- Sutter Neuroscience Institute - Sacramento, California, United States
- University of Colorado - Anschutz Medical Campus - Aurora, Colorado, 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
- University of New Mexico - Albuquerque, New Mexico, United States
- Northwell Health - Manhasset, 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
- 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
- Inland Northwest Research - Spokane, Washington, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- 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
- Centrum Medyczne Neuromed - Bydgoszcz, Poland
- Rambam Medical Center - Haifa, Israel
- London North West University Healthcare NHS Trust - Northwick Park Hospital - Harrow, United Kingdom
- Shaare Zedek Medical Center - Jerusalem, Israel
- NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski - Katowice, Poland
- Panthera Enfield - London, United Kingdom
- Pro Life Medica Sp. z o. o. ETA Lublin - Lublin, Poland
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa - Madrid, Spain
- IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia - Milan, Italy
- Hospital Universitario HM Puerta del Sur - Móstoles, Spain
- Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria - Naples, Italy
- Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica - Padua, Italy
Showing 60 of 72 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →