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RECRUITING
NCT06757010
PHASE2

A Study of NE3107 in Early Parkinson's

Sponsor: BioVie Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-03-26

Completion Date

2026-01-02

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

DRUG

NE3107

NE3107 20 mg BID

DRUG

Placebo

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