A Study of NE3107 in Early Parkinson's

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2026-01-02

Brief Summary

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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

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Detailed Description

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Conditions

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Parkinsons Disease (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NE3107

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

Group Type EXPERIMENTAL

NE3107

Intervention Type DRUG

NE3107 20 mg BID

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo BID

Interventions

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NE3107

NE3107 20 mg BID

Intervention Type DRUG

Placebo

Placebo BID

Intervention Type DRUG

Other Intervention Names

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bezisterim

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No