A Study of NE3107 in Early Parkinson's
A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
BioVie Inc.
60 participants
Mar 26, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria4
- 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
Interventions
Placebo BID
NE3107 20 mg BID
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06757010