A Study of NE3107 in Early Parkinson's (SUNRISE-PD)

April 23, 2026 updated by: BioVie Inc.

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Science 37 (Nationwide Site)
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuroscience Research Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NE3107
Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.
Drug: NE3107
NE3107 20 mg BID
Other Names:
  • bezisterim
Placebo Comparator: Placebo
Subjects will receive matching placebo capsules for oral administration BID (twice daily).
Drug: Placebo
Placebo BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the MDS-UPDRS Part III
Time Frame: 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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MDS-UPDRS Part I and II
Time Frame: 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.
12 weeks
Percent of subjects with improvement in Clinical Global Impression
Time Frame: 12 weeks
Percent of subjects with any improvement as measured by Clinical Global Impression.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioVie Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE3107-PD-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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