NCT06757010

A Study of NE3107 in Early Parkinson's

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: BioVie Inc. · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinsons Disease (PD)

Interventions

Type	Name	Description
DRUG	NE3107	NE3107 20 mg BID
DRUG	Placebo	Placebo BID

Timeline

• Start date: 2025-03-26
• Primary completion: 2025-12-01
• Completion: 2026-01-02
• First posted: 2025-01-03
• Last updated: 2025-07-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study