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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.