A Study of NE3107 in Early Parkinson's

Last updated: July 16, 2025
Sponsor: BioVie Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

NE3107

Clinical Study ID

NCT06757010
NE3107-PD-202
  • Ages 45-80
  • All Genders

Study Summary

The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are:

  • Will bezisterim decrease movement symptoms of Parkinson's disease?

  • What medical problems do participants have when taking bezisterim?

Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease.

Participants will

  • have a physical examination that includes an electrocardiogram

  • take drug or placebo twice daily for four months

  • visit a clinical site or receive an at home visit seven times over the course of five months

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 45 years to 80 years of age

  • diagnosed with idiopathic Parkinson's Disease (PD) within 18 months

  • nearing the need for symptomatic therapy

  • agree to use birth control measures

  • provide voluntary consent

  • willing to allow blood collection for DNA methylation analysis

  • pass all screening tests and procedures

Exclusion

Exclusion Criteria:

  • has taken levodopa or another similar drug for the motor symptoms of PD

  • a known or strongly suspected familial cause for PD diagnosis

  • major mental health or physical illness

  • medical history of major mental or physical illness

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 26, 2025
Estimated Completion Date:
January 02, 2026

Connect with a study center

  • Invicro

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Dent Neurologic

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Science 37

    Morrisville, North Carolina 27560
    United States

    Site Not Available

  • Science 37 (Nationwide Site)

    Morrisville, North Carolina 27560
    United States

    Active - Recruiting

  • NeuroScience Research Center, LLC

    Canton, Ohio 44718
    United States

    Active - Recruiting

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