A Study of NE3107 in Early Parkinson's

Phase 2

Recruiting

• Conditions: Parkinsons Disease (PD)
• Interventions: Drug: NE3107; Drug: Placebo

• Registration Number: NCT06757010
• Lead Sponsor: BioVie Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-03
• Status Verified: 2025-03
• Study Start: 2025-03-26
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NE3107	NE3107	Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.
Placebo	Placebo	Subjects will receive matching placebo capsules for oral administration BID (twice daily).

Primary Outcome Measures

Name	Time	Method
Change from baseline in the MDS-UPDRS Part III	12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in MDS-UPDRS Part I and II	12 weeks	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.
Percent of subjects with improvement in Clinical Global Impression	12 weeks	Percent of subjects with any improvement as measured by Clinical Global Impression.

Trial Locations

Locations (5)

Invicro; 🇺🇸 New Haven, Connecticut, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

Quest Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

Science 37 (Nationwide Site); 🇺🇸 Morrisville, North Carolina, United States

NeuroScience Research Center, LLC; 🇺🇸 Canton, Ohio, United States