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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
North Carolina
Science 37 (Nationwide Site)
RECRUITING
Morrisville
New York
Dent Neurologic
RECRUITING
Amherst
Ohio
NeuroScience Research Center, LLC
RECRUITING
Canton
Contact Information
Primary
Paul TanPiengco
ptanpiengco@bioviepharma.com
Backup
Clarence Ahlem
cahlem@bioviepharma.com
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2026-01-02
Participants
Target number of participants: 60
Treatments
Experimental: NE3107
Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.
Placebo_comparator: Placebo
Subjects will receive matching placebo capsules for oral administration BID (twice daily).
Related Therapeutic Areas
Sponsors
Leads: BioVie Inc.

This content was sourced from clinicaltrials.gov