Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 11
- 主要终点
- Change in Mobility: Timed 25 Foot Walk
研究概览
简要总结
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.
详细描述
This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of progressive MS as defined by the study
- •Able to give informed consent and to adhere to study procedures.
- •Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better.
排除标准
- •A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction
- •Unable to undergo MRI
- •Unable to follow directions in English as standardized scales are not all validated in other languages.
- •Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion.
- •Pregnant or breast-feeding.
- •Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications.
- •Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment.
- •IV or oral steroids in the 60 days prior to enrolment.
- •Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months.
- •Participation in the pilot LA in SPMS trial.
研究组 & 干预措施
Arm 1: Lipoic Acid
59 subjects receive oral lipoic acid 1200mg daily
干预措施: Lipoic acid (Drug)
Arm 2: Placebo
59 subjects receive placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mobility: Timed 25 Foot Walk
时间窗: 24 months
T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.
次要结局
- Change in Mobility: 2-minute Timed Walk(24 months)
- Mobility: Fall Count(24 months)
- Brain Atrophy by MRI(24 months)