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RECRUITINGPhase 2INTERVENTIONAL

A Study of NE3107 in Early Parkinson's

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

NE3107

NE3107 20 mg BID

DRUG

Placebo

Placebo BID

Locations (4)

Quest Research Institute
Farmington Hills, Michigan, United States
Dent Neurologic
Amherst, New York, United States
Science 37 (Nationwide Site)
Morrisville, North Carolina, United States
NeuroScience Research Center, LLC
Canton, Ohio, United States