A Study of NE3107 in Early Parkinson's

Description

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

Conditions

Parkinsons Disease (PD)

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Study Overview

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Study Details

Study overview

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

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

A Study of NE3107 in Early Parkinson's

Condition
Parkinsons Disease (PD)
Intervention / Treatment

-

Contacts and Locations

New Haven

Invicro, New Haven, Connecticut, United States, 06510

Chicago

Northwestern Medicine, Chicago, Illinois, United States, 60611

Farmington Hills

Quest Research Institute, Farmington Hills, Michigan, United States, 48334

Morrisville

Science 37, Morrisville, North Carolina, United States, 27560

Canton

NeuroScience Research Center, LLC, Canton, Ohio, United States, 44718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioVie Inc.,

Study Record Dates

2026-01-02