A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Part of paid clinical trials in Sun City, Arizona.
- Sponsor
- Neuron23 Inc.
- Study ID
- NCT06680830
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Early Parkinson Disease (Early PD)
- Idiopathic Parkinson Disease
- Parkinson
- Parkinson Disease
- Parkinson Disease, Idiopathic
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- NEU-411 — DRUGNEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
- Placebo — OTHEROrally-administered matched placebo
Study Details
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.
Key Dates
- Start date
- Jan 17, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: NEU-411Orally-administered NEU-411
- Placebo Comparator: PlaceboOrally-administered matching placebo
Primary Outcome Measure
Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo [ Time Frame: From enrollment to the end of treatment at 52 weeks ]
Central Contacts
- Fatta B Nahab, MD, FAAN, FANA650-228-2527
Locations (45)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | David Shprecher, DO (PRINCIPAL_INVESTIGATOR) |
| University of Arkansas | Little Rock | Arkansas | 72205 | Rohit Dhall, MD (PRINCIPAL_INVESTIGATOR) |
| Neuro-Pain Medical Center | Fresno | California | 93710 | Perminder Bhatia, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, Irvine | Irvine | California | 92697 | Sanaz Attaripour Isfahani, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, Los Angeles | Los Angeles | California | 90095 | Jeff Bronstein, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Esperanza Clinical | Murrieta | California | 92562 | Michael Ropacki, PhD (PRINCIPAL_INVESTIGATOR) |
| Parkinson's Research Centers of America - Palo Alto | Palo Alto | California | 94301 | Salima Brillman, MD (PRINCIPAL_INVESTIGATOR) |
| Sutter Neuroscience Institute | Sacramento | California | 95816 | Nicklesh Thakur, DO (PRINCIPAL_INVESTIGATOR) |
| University of Colorado - Anschutz Medical Campus | Aurora | Colorado | 80045 | Emily Forbes, DO (PRINCIPAL_INVESTIGATOR) |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | Stuart Isaacson, MD, FAAN (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32608 | Irene Malaty, MD (PRINCIPAL_INVESTIGATOR) |
| Neurology One | Orlando | Florida | 32825 | Ramon L Rodriguez, MD, FAAN (PRINCIPAL_INVESTIGATOR) |
| USF Parkinson's & Movement Disorders Clinic | Tampa | Florida | 33613 | Robert Hauser, MD, MBA, FAAN (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30329 | Brian Sperin Stewart Factor, DO (PRINCIPAL_INVESTIGATOR) |
| Augusta University | Augusta | Georgia | 30912 | John Morgan, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Medical Group, Department of Neurology | Chicago | Illinois | 60611 | Danielle N Larson, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Rajesh Pahwa, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kentucky | Lexington | Kentucky | 40536 | John Slevin, MD, MBA (PRINCIPAL_INVESTIGATOR) |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | David Houghton, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland | Baltimore | Maryland | 21201 | Joseph Savitt, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Ludy Shih, MD, MMSc (PRINCIPAL_INVESTIGATOR) |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | Aaron Ellenbogen, DO, MPH (PRINCIPAL_INVESTIGATOR) |
| Struthers Parkinson Center | Golden Valley | Minnesota | 55427 | Sotirios Parashos, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Las Vegas | Nevada | 89106 | Zoltan Mari, MD (PRINCIPAL_INVESTIGATOR) |
| University of New Mexico | Albuquerque | New Mexico | 87106 | Sarah P Richardson, MD, FAAN (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | Great Neck | New York | 11021 | Ritesh Ramdhani, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | Sheng-Han Kuo, MD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai/Mount Sinai West | New York | New York | 10019 | Joohi Jimenez-Shahed, MD (PRINCIPAL_INVESTIGATOR) |
| University of Rochester | Rochester | New York | 14618 | Christopher Tarolli, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | Daniel Roque, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University | Columbus | Ohio | 43210 | Ariane Park, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | Kevin Klos, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | Joseph Quinn, MD (PRINCIPAL_INVESTIGATOR) |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Tsao-Wei Liang, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Christine Cooper, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University | Nashville | Tennessee | 37232 | David Charles, MD (PRINCIPAL_INVESTIGATOR) |
| Neurology Consultants of Dallas PA | Dallas | Texas | 75243 | Nirav Pavasia, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor College of Medicine | Houston | Texas | 77030 | Arjun Tarakad, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Raja Mehanna, MD (PRINCIPAL_INVESTIGATOR) |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | Elizabeth Peckham, DO (PRINCIPAL_INVESTIGATOR) |
| University of Utah Movement Division | Salt Lake City | Utah | 84108 | Paolo Moretti, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia | Charlottesville | Virginia | 22903 | Binit Shah, MD, FAAN (PRINCIPAL_INVESTIGATOR) |
| EvergreenHealth | Kirkland | Washington | 98034 | Pinky Agarwal, MD, FAAN (PRINCIPAL_INVESTIGATOR) |
| Inland Northwest Research | Spokane | Washington | 99202 | Jason Aldred, MD (PRINCIPAL_INVESTIGATOR) |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Karen Blindauer, MD (PRINCIPAL_INVESTIGATOR) |
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