A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease

Last updated: March 6, 2025
Sponsor: Neuron23 Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

NEU-411

Clinical Study ID

NCT06680830
NEU-411-PD201
  • Ages 50-80
  • All Genders

Study Summary

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 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.

Participants will:

• Take NEU-411 or placebo every day for 52 weeks

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 50-80 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

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 are outlined in the full study protocol.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 17, 2025
Estimated Completion Date:
September 30, 2027

Study Description

NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study 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 study, approximately 150 participants will be randomized in a 1:1 allocation ratio to NEU-411 30 mg once per day or placebo for a 52-week treatment period. A safety follow-up visit will occur 2 weeks after the last treatment visit.

Connect with a study center

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Neurology One

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • Northwestern Medical Group, Department of Neurology

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Struthers Parkinson Center

    Golden Valley, Minnesota 55427
    United States

    Active - Recruiting

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