A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)
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)
Sponsor: Neuron23 Inc.
A observational or N/A phase clinical study on Early Parkinson Disease (Early PD) and Idiopathic Parkinson Disease, this trial is actively recruiting participants. The trial is conducted by Neuron23 Inc. and has accumulated 14 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
14 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
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Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE2
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE2
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE2
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE2
▶ Show 9 earlier versions
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE2
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE2
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE2
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE2
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE2
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE2
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Feb 2025 — Mar 2025 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Dec 2024 — Feb 2025 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
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.
Contact Information
- Neuron23 Inc.
- Qiagen Manchester Limited
- Roche Diagnostic Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .