At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- NEU-411 (drug), Placebo (other)
- How long the study runs
- Study runs about 41 months (dates as stated)
- About the drug or intervention
- NEU-411 — drug: NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity · Placebo — other: Orally-administered matched placebo
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a phase 2 study (a mid-stage trial to test how well a medicine works) of a treatment called NEU-411 in people with early Parkinson's disease. It also includes an open-label extension, which means a period where everyone can receive the treatment knowing what it is. The study is for people whose Parkinson's is linked to a change in a gene called LRRK2, which will be checked using a special investigational genetic test. The sponsor is Neuron23 Inc.
Who can take part
- Aged 40 to 80 years at screening
- Diagnosed with clinically established or clinically probable Parkinson's disease
- Parkinson's driven by the LRRK2 gene, shown by the study's investigational genetic test (called a companion diagnostic)
- Mild to moderate disease, measured as modified Hoehn and Yahr stage 1 to 2.5
Who may not be able to
- Parkinson's-like conditions that are secondary or atypical (not typical Parkinson's disease)
- Uncontrolled diabetes with HbA1c (a blood sugar measure) above 8%
- Other significant medical conditions, as judged by the study team from your medical history, examination or tests at screening
What taking part involves
- • Taking the study medicine NEU-411 — details of doses or how it is taken are not stated — ask the trial team
- • Taking part in a phase 2 main study followed by an open-label extension where all participants receive the treatment — details are not stated — ask the trial team
Time commitment: Not stated — ask the trial team (number of visits, how long the study lasts, and what taking part involves are not stated in the data above)
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 40 Years to 80 Years
- Who
- All
- Number of participants
- 150
- Started
- 2025-01-17
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for parkinson disease
- • Phase2 - 150 participants
- • 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
Who can take part?
- • Ages 40 Years to 80 Years
- • Diagnosed with parkinson disease
Where?
- • London - St George's Hospital, University of London
- • London - University College London Hospitals NHS Foundation Trust
- • Newcastle upon Tyne - Clinical Aging Research Unit, Newcastle University
- • Dundee - Ninewells Hospital and Medical School - NHS Tayside
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study and open-label extension (OLE) 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 randomized, placebo-controlled portion of the study, approximately 150 participants will be randomized in a 1:1 allocation to NEU-411 30 mg once per day or placebo for a 52-week treatment period with a safety follow-up visit within 2 weeks after the last treatment visit. Eligible participants may enroll in the OLE and receive treatment for an additional 26 weeks.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Secondary or atypical parkinsonian syndromes
- ✗Uncontrolled diabetes mellitus with red blood cell level A1c (HbA1c) \>8%
- ✗Other significant medical conditions (as determined by medical history, examination, or clinical investigations at...
- ✗Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.
See the full criteria
Where Is This Study? (6 UK sites)
St George's Hospital, University of London
London SW17 0QT, United Kingdom
University College London Hospitals NHS Foundation Trust
London WC1N 3BG, United Kingdom
Clinical Aging Research Unit, Newcastle University
Newcastle upon Tyne NE4 5PL, United Kingdom
Ninewells Hospital and Medical School - NHS Tayside
Dundee DD19SY, United Kingdom
London North West University Healthcare NHS Trust - Northwick Park Hospital
Harrow HA1 3UJ, United Kingdom
Panthera Enfield
London EN3 4GS, United Kingdom
How to Get in Touch
Fatta B Nahab, MD, FAAN, FANA
Sponsor contactCONTACT