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NCT Number: NCT06680830

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Early Parkinson Disease (Early PD) Idiopathic Parkinson Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Parkinson Disease, Idiopathic Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rambam Medical Center, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Secondary or atypical parkinsonian syndromes
  • Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
  • 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.

Treatment and study plan

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

Primary outcomes

  1. Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo

    Time frame: From enrollment to the end of treatment at 52 weeks

  2. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo

    Time frame: From enrollment to the end of study at 54 weeks

Secondary outcomes

  1. Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Time frame: 52 weeks

    Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Study contacts

Contact information is provided by the study sponsor or research team.

Fatta B Nahab, MD, FAAN, FANA

CONTACT

[email protected]

650-228-2527

Sponsors and collaborators

Lead sponsor

Neuron23 Inc.

Industry

Collaborators

  • Qiagen Manchester Limited
  • Roche Diagnostic Ltd.

Registry information

Official study 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)

Acronym: NEULARK

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 8, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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