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 (NEULARK)
Details
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.
Eligibility
You can join if...
Inclusion Criteria:
Aged 50-80 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) greater than 8%
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.