A Study of NE3107 in Early Parkinson's

Phase 2Active Not RecruitingNCT06757010

BioVie Inc.60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinsons Disease (PD)

Interventions

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (4)

Quest Research Institute

Farmington Hills, Michigan, United States

Dent Neurologic

Amherst, New York, United States

Science 37 (Nationwide Site)

Morrisville, North Carolina, United States

NeuroScience Research Center, LLC

Canton, Ohio, United States

Outcomes

Primary Outcomes

Change from baseline in the MDS-UPDRS Part III

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is comprised of 4 parts: This study will use MDS-UPDRS Parts I, II, and III. The primary efficacy endpoint is change in the modified MDS-UPDRS Part III score. Scores (0-4: Normal to severe impact) are derived from clinician and subject input to allow the assessment of symptomatic worsening, stability, or improvement.

Time frame: 12 Weeks

Secondary Outcomes

Change from baseline in MDS-UPDRS Part I and II

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is comprised of 4 parts: This study will use MDS-UPDRS Parts I, II, and III. Secondary efficacy endpoints in the study will include change in the modified MDS-UPDRS Part I and II scores. Scores (0-4: Normal to severe impact) are derived from clinician and subject input to allow the assessment of symptomatic worsening, stability, or improvement.

Time frame: 12 weeks

Percent of subjects with improvement in Clinical Global Impression

Percent of subjects with any improvement as measured by Clinical Global Impression.

Time frame: 12 weeks