Testing NE3107 for treating early Parkinson's disease symptoms
A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
This study is testing if a new medication called bezisterim can help people aged 45 to 80 with early Parkinson's disease feel better by reducing their movement symptoms before they start other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | BioVie Inc. Industry-sponsored |
| Locations | 5 sites (New Haven, Connecticut and 4 other locations) |
| Trial ID | NCT06757010 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of bezisterim in reducing movement symptoms in treatment-naïve patients with early Parkinson's disease, aged 45 to 80. Participants will be randomly assigned to receive either bezisterim or a placebo for four months, with regular assessments to monitor their symptoms and any potential side effects. The study will involve physical examinations, including electrocardiograms, and will require participants to attend multiple visits over five months. The primary goal is to determine if bezisterim can provide relief from movement symptoms before patients start traditional therapies like levodopa.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 80 who have been diagnosed with idiopathic Parkinson's disease within the last 18 months and are nearing the need for symptomatic therapy.
Not a fit: Patients who have already started treatment with levodopa or similar medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for managing early Parkinson's disease symptoms without the immediate need for levodopa.
How similar studies have performed: While this approach is exploring a new treatment option, similar studies have shown promise in targeting early symptoms of Parkinson's disease with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 4 other locations
- Invicro — New Haven, Connecticut, United States (Not_yet_recruiting)
- Northwestern Medicine — Chicago, Illinois, United States (Not_yet_recruiting)
- Quest Research Institute — Farmington Hills, Michigan, United States (Recruiting)
- Science 37 (Nationwide Site) — Morrisville, North Carolina, United States (Recruiting)
- NeuroScience Research Center, LLC — Canton, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Paul TanPiengco
- Email: ptanpiengco@bioviepharma.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.