A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
- Conditions
- Parkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, Idiopathic
- Interventions
- Other: Placebo
- Registration Number
- NCT06680830
- Lead Sponsor
- Neuron23 Inc.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Aged 50-80 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
- 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 are outlined in the full study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NEU-411 NEU-411 Orally-administered NEU-411 Placebo Placebo Orally-administered matching placebo
- Primary Outcome Measures
Name Time Method Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo From enrollment to the end of treatment at 52 weeks Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo From enrollment to the end of study at 54 weeks
- Secondary Outcome Measures
Name Time Method Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 52 weeks Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Trial Locations
- Locations (43)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United 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
Parkinson's Research Centers of America - Palo Alto
🇺🇸Palo Alto, California, United States
Adaptive Research - California Neuro Institute
🇺🇸San Jose, California, United States
University of Colorado - Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Invicro
🇺🇸New Haven, Connecticut, 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
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
Darthmouth-Hitchcock Medical Center - Parkinson's Center
🇺🇸Lebanon, New Hampshire, United States
Northwell Health
🇺🇸Great Neck, 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
Velocity Clinical Research at Raleigh Neurology
🇺🇸Raleigh, 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
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, 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
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States