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NCT06757010 | RECRUITING | Parkinsons Disease (PD)

A Study of NE3107 in Early Parkinson's
Sponsor:

BioVie Inc.

Brief 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

Condition or disease

Parkinsons Disease (PD)

Intervention/treatment

NE3107

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
Actual Study Start Date : 2025-03-26
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2026-01-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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
A Study of NE3107 in Early Parkinson's

Location Details

NCT06757010

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, road cancer

Quest Research Institute

Farmington Hills, road cancer, United States, 48334

RECRUITING

United States, New York

Dent Neurologic

Amherst, New York, United States, 14226

RECRUITING

United States, North Carolina

Science 37 (Nationwide Site)

Morrisville, North Carolina, United States, 27560

RECRUITING

United States, Ohio

NeuroScience Research Center, LLC

Canton, Ohio, United States, 44718