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

BioVie

Status and phase: Enrolling; Phase 2

Conditions: Parkinsons Disease (PD)

Treatments: Drug: Placebo; Drug: NE3107

Study type: Interventional

Funder types: Industry

Identifiers

NCT06757010

NE3107-PD-202

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

NE3107

Experimental group

Description:

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

Treatment:

Drug: NE3107

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo