RecruitingPhase 2NCT06757010

A Study of NE3107 in Early Parkinson's

A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease


Sponsor

BioVie Inc.

Enrollment

60 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called NE3107 can slow the progression of early Parkinson's disease. NE3107 targets inflammation in the brain, which may be an underlying cause of Parkinson's symptoms. **You may be eligible if...** - You are between 45 and 80 years old - You were diagnosed with Parkinson's disease within the last 18 months - You are approaching the point where you would need medication for your movement symptoms, but have not yet started - You agree to blood tests and DNA analysis **You may NOT be eligible if...** - You have already started taking levodopa or similar Parkinson's medications - Your Parkinson's is likely inherited (familial cause) - You have a serious mental or physical health condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNE3107

NE3107 20 mg BID

DRUGPlacebo

Placebo BID


Locations(4)

Quest Research Institute

Farmington Hills, Michigan, United States

Dent Neurologic

Amherst, New York, United States

Science 37 (Nationwide Site)

Morrisville, North Carolina, United States

NeuroScience Research Center, LLC

Canton, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06757010


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