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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study

UCI Specialty Area: Neurology
Principal Investigator: Sanaz Attaripour Isfahani
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 (NEULARK)
A Study On:
Parkinson Disease

Study 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.

Eligibility

  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
  1. Secondary or atypical parkinsonian syndromes
  2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) greater than 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.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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