NCT06757010

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
0mo left

Started Mar 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2025May 2026

First Submitted

Initial submission to the registry

December 24, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

December 24, 2024

Last Update Submit

April 23, 2026

Conditions

Parkinsons Disease (PD)

Keywords

Treatment naïve Parkinson'sEarly Parkinson's

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Weeks

Secondary Outcomes (2)

  • Change from baseline in MDS-UPDRS Part I and II

    12 weeks

  • Percent of subjects with improvement in Clinical Global Impression

    12 weeks

Study Arms (2)

NE3107

EXPERIMENTAL

Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.

Drug: NE3107

Placebo

PLACEBO COMPARATOR

Subjects will receive matching placebo capsules for oral administration BID (twice daily).

Drug: Placebo

Interventions

NE3107DRUG

NE3107 20 mg BID

Also known as: bezisterim
NE3107
PlaceboDRUG

Placebo BID

Placebo

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Dent Neurologic

Amherst, New York, 14226, United States

Location

Science 37 (Nationwide Site)

Morrisville, North Carolina, 27560, United States

Location

NeuroScience Research Center, LLC

Canton, Ohio, 44718, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 3, 2025

Study Start

March 26, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)