Propionic Acid in Multiple Sclerosis: Safety, Tolerability and Clinical Outcomes From the Pro-MADAI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this study is to explore the long-term safety, tolerability, and clinical efficacy of propionic acid as an add-on therapy in multiple sclerosis (MS).
详细描述
This study is a prospective, open-label extension of the placebo-controlled MADAI trial, including 22 patients with stable relapsing-remitting multiple sclerosis. Participants received oral PA (500 mg twice daily) for an additional 9 months follow-up (FU). Multimodal assessments included safety and tolerability, cognitive testing (SDMT), physical performance (9HPT, 10mWT), and patient-reported outcome measurements PROMs (SF-36, FSMC, ESS, BDI-II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older 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 70 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
- •History of ongoing propionic acid (PA) supplementation exceeding 3 months
- •Positive JC virus titer during natalizumab treatment
- •Presence of severe active systemic disease
- •Presence of acute neurological conditions
研究组 & 干预措施
Observational control cohort
Participants who received no further PA supplementation are identified through routine clinical follow-up after completion of the MADAI trial.
Propionic acid 1000 mg
Participants recruited from the MADAI trial receive oral PA 500 mg twice daily for an additional 9-month follow-up period.
干预措施: Propionic acid 1000 mg capsule (Dietary Supplement)
结局指标
主要结局
Safety and tolerability
时间窗: 9 months
Treatment-Emergent Adverse Events Number of participants experiencing at least one treatment-emergent adverse event during the study, as assessed through participant reports, patient diaries, and routine laboratory assessments.
次要结局
- Symbol Digit Modalities Test (SDMT)(9 months)
- Nine-Hole Peg Test (9HPT)(9 months)
- 10-Meter Walk Test (10mWT)(9 months)
- Short Form Health Survey (SF-36)(9 months)
- Fatigue Scale for Motor and Cognitive Functions (FSMC)(9 months)
- Epworth Sleepiness Scale (ESS)(9 months)
- Beck Depression Inventory-II (BDI-II)(9 months)
研究者
Tobias Moser
Principal Investigator
Salzburger Landeskliniken