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A Study of NE3107 in Early Parkinson's

NCT06757010 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-28

No results posted yet for this study

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

DRUG

NE3107

NE3107 20 mg BID

DRUG

Placebo

Placebo BID

Sponsors & Collaborators

  • BioVie Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2026-05-01
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06757010 on ClinicalTrials.gov