A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
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)
Neuron23 Inc.
150 participants
Jan 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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)
Interventions
NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity
Orally-administered matched placebo
Locations(69)
View Full Details on ClinicalTrials.gov
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NCT06680830