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NCT06680830 | NOT YET RECRUITING | Parkinson Disease

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

Neuron23 Inc.

Brief 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

Condition or disease

Parkinson Disease

Parkinson

Idiopathic Parkinson Disease

Early Parkinson Disease (Early PD)

Parkinson Disease, Idiopathic

Intervention/treatment

NEU-411

Placebo

Phase

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : QUADRUPLE
Masking Description : The Sponsor is also masked.
Primary Purpose : TREATMENT
Official Title : A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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.
A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease

Location Details

NCT06680830

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How to Participate

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Locations

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