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A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

Sponsored by Neuron23 Inc.

About this study

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.

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…

Where this study is enrolling (45)

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Who can participate

Inclusion criteria

  • ✓1. Aged 40-80 years at time of screening, inclusive
  • ✓2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
  • ✓3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
  • ✓4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5

Exclusion criteria

  • ✕1. Secondary or atypical parkinsonian syndromes
  • ✕2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
  • ✕3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)
  • ✕Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.

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Trial data sourced from ClinicalTrials.gov.