Propionic Acid in Multiple Sclerosis - a Placebo-controlled Randomized Double-blinded Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Serum neurofilament light chain (NfL)
研究概览
简要总结
The purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (MS).
详细描述
This is a single-center, double-blinded, randomized trial. One hundred multiple sclerosis (MS) patients will be randomly assigned in a 2:1 ratio to receive either 100 mg of propionic acid or a placebo over a period of 90 days. Outcome measures will encompass NfL and GFAP levels, fatigue scores, quality of life assessments, and physical examinations. Additionally, subgroup analysis will involve the evaluation of MRI and MEG data.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis (MS)
- •Clinically and radiologically stable MS in the previous 3 months
- •Age between 18 and 60 years
- •Positive finding for oligoclonal bands (OCBs)
- •Written consent
- •Blood collection at the beginning and end of the study for routine parameter examination as well as sample preservation (especially for measuring propionic acid levels)
- •Negative pregnancy test for female participants of childbearing age
排除标准
- •Existing propionic acid supplementation
- •Change in disease-modifying therapy (DMT) in the previous 4 weeks
- •Existing severe systemic diseases
- •Presence of other concomitant structural nerve diseases (e.g., polyneuropathy, brain tumor, strokes)
- •High JCV titer under Natalizumab
研究组 & 干预措施
Propionic acid 1000 mg
干预措施: Propionic acid 1000 mg capsule (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Serum neurofilament light chain (NfL)
时间窗: 90 days
assessed as pg/ml
Serum glial fibrillary acid protein (GFAP)
时间窗: 90 days
assessed as pg/ml
次要结局
- Magnetoencephalography (MEG)(90 days)
- Fatigue Scale for Motor and Cognitive Functions (FSMC)(90 days)
- Walking test, 10 meters distance(90 days)
- cerebral MRI(90 days)
- 9-hole peg test(90 days)
- 36-Item Short Form Health Survey (SF-36)(90 days)
研究者
Tobias Moser
Principal Investigator
Salzburger Landeskliniken