A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA.
研究概览
简要总结
The purpose of this study is to learn about an investigational drug known as oral lipoic acid (LA) that may help treat multiple sclerosis. This study will measure how a person's body absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of the drug from four different manufacturers as well as LA in conjunction with fish oil.
详细描述
Multiple sclerosis (MS) is a common, often disabling inflammatory disease of the central nervous system (CNS). Present treatments for MS are only partially effective, available only in injectable forms, have significant side effects and are very costly. Developing more effective and better-tolerated treatments of MS thus remains an important goal for the improvement of the care of MS. Lipoic acid (LA) is an antioxidant that is widely available as a dietary supplement.
The primary outcome of this study is to determine the pharmacokinetics of oral LA 1200 mg to see if we can identify factors affecting the bioavailability of LA. We will also study the salivary concentrations of oral LA and its correlation with the serum LA concentrations. We will also study the effects of LA on the immunological markers after four hours of administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS by McDonald's or Poser's criteria
- •EDSS ≤ 7.5
- •Age 18 to 80
排除标准
- •No clinically significant MS exacerbation within 30 days of the screening
- •No systemically administered corticosteroids within 30 days of study entry
- •Patient not pregnant or breast feeding
- •No LA in previous 2 weeks
- •Not on anti-coagulants such as heparin, coumadin, or aspirin during study
- •No other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events
- •Inability to give informed consent
- •Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
A
This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
干预措施: oral lipoic acid (LA) (Drug)
B
This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.
干预措施: lipoic acid (LA) with fish oil and LA without fish oil (Drug)
C
This arm will include the study of a single dose of R enantiomer lipoic acid.
干预措施: R lipoic acid (Drug)
结局指标
主要结局
To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA.
时间窗: November 2008
次要结局
- To study salivary LA concentrations corresponding to the serum levels.(November 2008)
研究者
Vijayshree Yadav
Principal Investigator
Oregon Health and Science University