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Active, Not Recruiting

NCT Number: NCT06757010

A Study of NE3107 in Early Parkinson's

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parkinsons Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Quest Research Institute, Farmington Hills, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NE3107

Drug

NE3107 20 mg BID

Other names: bezisterim

Placebo

Drug

Placebo BID

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

BioVie Inc.

Industry

Registry information

Official study title

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

Acronym: SUNRISE-PD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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