MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Modified Fatigue Inventory Scale (MFIS)
研究概览
简要总结
The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.
详细描述
Recruitment of subjects on hold due to COVID-19 pandemic
MitoQ is a potent antioxidant dietary supplement with potentially significant immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal energy depletion may be an important contributor to fatigue in MS.
This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It will also explore the effects of MitoQ on cognitive function, quality of life and mood. If enrolled in the study, patients will take two capsules of the study drug or placebo at the same time every day for twelve weeks. There will be 4 study visits where the participant will undergo medical and nervous system examinations, questionnaires, and blood draws. Because it is a placebo-controlled trial, participants will have a 33% chance of receiving either placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study, meaning neither the participant nor the investigator will know who received the placebo or study drug.
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
- Double (Participant, Investigator)
盲法说明
The subject and investigator will be blinded.
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
- •MS (any clinical subtype) as diagnosed by the 2017 McDonald criteria
- •EDSS score of 2 to 8
- •complaint of fatigue that has been persistent for at least two months
- •Modified Fatigue Impact Scale (MFIS) score of 38 or greater
排除标准
- •treatment with systemic glucocorticoids in the prior six weeks
- •Beck Depression Inventory (BDI) >31 or BDI-FS>10 (severe depression)
- •significant MS exacerbation in prior 30 days
- •previous use of MitoQ or Coenzyme Q10 (CoQ10) within thirty days of screening appointment
- •other significant health problem that might increase risk of patient experiencing Adverse Events (AEs), e.g.:
- •active coronary heart disease
- •liver disease
- •pulmonary disease
- •diabetes mellitus
- •pregnancy or intending to become pregnant or breastfeeding
- •unable to complete the self-report forms
- •unable to give informed consent
- •prisoners
- •any condition which would make the patient in the opinion of the investigator unsuitable for the study
研究组 & 干预措施
20mg of MitoQ
20mg of oral mitoquinol
干预措施: 20 mg MitoQ (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
40mg of MitoQ
40mg of Oral Mitoquinol
干预措施: 40mg of MitoQ (Drug)
结局指标
主要结局
Modified Fatigue Inventory Scale (MFIS)
时间窗: Week 1, Week 7, Week 13
MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.
次要结局
- Expanded Disability Status Scale (EDSS)(12 weeks)
- Beck's Depression Inventory (BDI)(12 weeks)
- Symbol Digit Modalities Test (SDMT)(Week 1, Week 7, Week 13)
- Expanded Disability Status Scale (EDSS)(12 weeks)
- Beck's Depression Inventory (BDI)(12 weeks)