A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- BioVie Inc.
- 入组人数
- 57
- 试验地点
- 8
- 主要终点
- Change from baseline in the MDS-UPDRS Part III
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NE3107
Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.
干预措施: NE3107 (Drug)
Placebo
Subjects will receive matching placebo capsules for oral administration BID (twice daily).
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the MDS-UPDRS Part III
时间窗: 12 Weeks
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is comprised of 4 parts: This study will use MDS-UPDRS Parts I, II, and III. The primary efficacy endpoint is change in the modified MDS-UPDRS Part III score. Scores (0-4: Normal to severe impact) are derived from clinician and subject input to allow the assessment of symptomatic worsening, stability, or improvement.
Monocyte Lymphocyte Ratio (MLR)
时间窗: 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)
次要结局
- Change from baseline in MDS-UPDRS Part I and II(12 weeks)
- Percent of subjects with improvement in Clinical Global Impression(12 weeks)
- Change in Systemic Inflammation Response Index (SIRI)(12 weeks)
- Change in Neutrophil-to-Lymphocyte Ratio (NLR)(12 weeks)
- Change in Systemic Immune-Inflammation Index (SII)(12 weeks)
- Change in Platelet-to-Lymphocyte Ratio (PLR)(12 weeks)
- Change in Aggregate Index of Systemic Inflammation (AISI)(12 weeks)
- Change in the Composite Benefit Score (CBS)(12 weeks)
- Change in MDS-UPDRS modified Part III(12 weeks)
- Change in MDS-UPDRS Part II scores(12 weeks)
- Change in MDS-UPDRS Part I scores(12 weeks)
- Change in MDS-UPDRS combined scores(12 weeks)
- Change in PDQ-39 score(12 weeks)
- Clinician's General Impression of Improvement (CGI-I)(12 weeks)
- Clinician's General Impression of Severity (CGI-S)(12 weeks)
- Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)(12 weeks)