Parkinsons Disease (PD)
Conditions
Keywords
Treatment naïve Parkinson's, Early Parkinson's
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
Interventions
DRUGNE3107
NE3107 20 mg BID
DRUGPlacebo
Placebo BID
Sponsors
BioVie Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocyte Lymphocyte Ratio (MLR) | 12 Weeks | A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systemic Inflammation Response Index (SIRI) | 12 weeks | A unitless measure of systemic inflammation calculated as the product of the absolute blood neutrophil count and absolute blood monocyte count divided by the absolute blood lymphocyte count in samples obtained for clinical hematology testing. |
| Change in Neutrophil-to-Lymphocyte Ratio (NLR) | 12 weeks | A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood neutrophil count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments. |
| Change in Systemic Immune-Inflammation Index (SII) | 12 weeks | A unitless composite measure of systemic inflammation and immune status calculated as the product of the absolute peripheral blood platelet count and neutrophil count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments. |
| Change in Platelet-to-Lymphocyte Ratio (PLR) | 12 weeks | A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood platelet count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments. |
| Change in Aggregate Index of Systemic Inflammation (AISI) | 12 weeks | A unitless composite measure of systemic inflammation calculated as the product of the absolute peripheral blood neutrophil count, monocyte count, and platelet count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments. |
| Change in the Composite Benefit Score (CBS) | 12 weeks | Early Parkinson's Neuro-Inflammatory Composite-15 (EPNIC-15), a composite endpoint consisting of 15 clinically relevant motor and non-motor measures derived from MDS-UPDRS Parts I, II, and III and PDSS-2 assessments. Lower scores indicate improvement in Parkinson's disease symptoms. |
| Change in MDS-UPDRS modified Part III | 12 weeks | Change from baseline in MDS-UPDRS Modified Part III score, a clinician-rated measure of Parkinson's disease motor signs assessed using a modified Part III examination. The scale evaluates motor manifestations including speech, tremor, rigidity, bradykinesia, gait, posture, and postural stability. Higher scores indicate worse motor impairment. |
| Change in MDS-UPDRS Part II scores | 12 weeks | Change from baseline in MDS-UPDRS Part II score. MDS-UPDRS Part II assesses the impact of Parkinson's disease motor symptoms on activities of daily living, with higher scores indicating greater impairment and negative changes indicating improvement. |
| Change in MDS-UPDRS Part I scores | 12 weeks | Change from baseline in MDS-UPDRS Part I score. MDS-UPDRS Part I assesses non-motor experiences of daily living in Parkinson's disease, with higher scores indicating greater symptom burden and negative changes indicating improvement. |
| Change in MDS-UPDRS combined scores | 12 weeks | Change from baseline in the combined MDS-UPDRS score (Parts I + II + III). The combined score assesses overall Parkinson's disease burden across non-motor symptoms, activities of daily living, and motor signs, with higher scores indicating greater impairment and negative changes indicating improvement. |
| Change in PDQ-39 score | 12 weeks | Change from baseline in PDQ-39 total score. The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across eight domains affected by Parkinson's disease. Higher scores indicate worse quality of life and negative changes indicate improvement. |
| Clinician's General Impression of Improvement (CGI-I) | 12 weeks | Clinician's Global Impression of Improvement (CGI-I) score. The CGI-I is a clinician-rated measure of overall change in a participant's condition compared with baseline, scored on a 7-point scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement. |
| Clinician's General Impression of Severity (CGI-S) | 12 weeks | Change from baseline in Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater severity and negative changes indicate improvement. |
| Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores) | 12 weeks | Change from baseline in modified PARCOMS-Motor score. PARCOMS-Motor is a composite measure of Parkinson's disease motor symptoms derived from MDS-UPDRS motor assessments. The score was modified to adjust for missing MDS-UPDRS Part III data. Higher scores indicate greater motor impairment and negative changes indicate improvement |
Countries
United States
Outcome results
None listed