Slow early Parkinson disease progression
- Trial ID
- NCT06680830
- Official Title
- 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)
- Goal
- Slow early Parkinson disease progression
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Neuron23 Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease (Early PD), Parkinson Disease, Idiopathic
- Interventions
- NEU-411, Placebo
Plain-Language Summary
They are testing whether NEU-411 can slow or modify early Parkinson's that is driven by mutations in the LRRK2 gene, by reducing the harmful LRRK2-related processes that may damage nerve cells. NEU-411 is an experimental drug given versus placebo to people who test positive on a companion genetic diagnostic, it is designed to inhibit overactive LRRK2 enzyme activity and would be used alongside standard symptomatic treatments like levodopa rather than replacing them. The trial is looking for adults 40 to 80 years old with clinically established or probable early Parkinson's, Hoehn and Yahr stage 1 to 2.5, who are LRRK2-CDx positive, while excluding atypical parkinsonism, uncontrolled diabetes, and other major medical problems.
Locations
- 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
And 50 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying NEU-411. They are testing whether NEU-411 can slow or modify early Parkinson's that is driven by mutations in the LRRK2 gene, by reducing the harmful LRRK2-related processes that may damage nerve cells. NEU-411 is an experimental drug given versus placebo to people who test positive on a companion genetic diagnostic, it is designed to inhibit overactive LRRK2 enzyme activity and would be used alongside standard symptomatic treatments like levodopa rather than replacing them. The trial is looking for adults 40 to 80 years old with clinically established or probable early Parkinson's, Hoehn and Yahr stage 1 to 2.5, who are LRRK2-CDx positive, while excluding atypical parkinsonism, uncontrolled diabetes, and other major medical problems.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 70 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 7 months.