RECRUITING

A Study of NE3107 in Early Parkinson's

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-02
Study Completion:2026-01-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06757010

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.

Ages Eligible for Study:45 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 45 years to 80 years of age
  2. * diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
  3. * nearing the need for symptomatic therapy
  4. * agree to use birth control measures
  5. * provide voluntary consent
  6. * willing to allow blood collection for DNA methylation analysis
  7. * pass all screening tests and procedures
  1. * has taken levodopa or another similar drug for the motor symptoms of PD
  2. * a known or strongly suspected familial cause for PD diagnosis
  3. * major mental health or physical illness
  4. * medical history of major mental or physical illness

Contacts and Locations

Study Contact

Paul TanPiengco
CONTACT
ptanpiengco@bioviepharma.com
Clarence Ahlem
CONTACT
cahlem@bioviepharma.com

Study Locations (Sites)

Invicro
New Haven, Connecticut, 06510
United States
Northwestern Medicine
Chicago, Illinois, 60611
United States
Quest Research Institute
Farmington Hills, Michigan, 48334
United States
Science 37
Morrisville, North Carolina, 27560
United States
NeuroScience Research Center, LLC
Canton, Ohio, 44718
United States

Collaborators and Investigators

Sponsor: BioVie Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2026-01-02

Study Record Updates

Study Start Date2025-02
Study Completion Date2026-01-02

Terms related to this study

Keywords Provided by Researchers

  • Treatment naïve Parkinson's
  • Early Parkinson's

Additional Relevant MeSH Terms

  • Parkinsons Disease (PD)