Lipoic Acid for Neuroprotection in Secondary Progressive MS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Brain Atrophy by MRI
研究概览
简要总结
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
详细描述
There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SPMS
- •Age 40-70 years
- •Able to understand English and able to give informed consent
排除标准
- •Unable to undergo MRI testing
- •For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
- •For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
- •Pregnant or breast-feeding.
- •Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
- •Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
- •Other immunosuppressants or chemotherapies taken in the last 12 months
- •Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
- •IV or oral steroids taken in the past 60 days.
- •Lipoic acid taken in the past 60 days.
- •Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
研究组 & 干预措施
Arm 1: lipoic acid
28 subjects receive oral lipoic acid 1200mg daily
干预措施: lipoic acid (Drug)
Arm 2: placebo
28 subjects receive placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
Brain Atrophy by MRI
时间窗: % change brain volume from baseline to year 2
次要结局
- Disability Measures: Mobility(Change in Timed 25 Foot Walk from baseline to year 2)
- Safety Measure: Adverse Events(adverse events recorded from baseline to year 2)