NCT01067573已完成不适用
The Role of Leptin Levels in Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fasting leptin and nitric oxide testing
研究概览
简要总结
To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients.
详细描述
This is an observational pilot study in patients with definitive relapsing-remitting multiple sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric oxide levels during a clinically observed increase in disease activity. Each subject will followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a week.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of multiple sclerosis per update of McDonald criteria
- •Initiating treatment with interferon beta 1a subcutaneous injection with minimal dosing of 22mcg.
- •18-60 years of age.
- •Women who are not pregnant or breast feeding, and who do not intend to become pregnant.
- •Stable dose of concomitant medications for 30 days prior to baseline. Efforts should be made to maintain steady doses of concomitant medications for the duration of the study.
排除标准
- •Treatment on other interferon preparations, glatiramer acetate, in last 30 days or 6 months on Natalizumab, mitoxantrone, cyclosporine or other immunomodulators as determined by the PI.
- •Treatment with any other investigational treatments within the past year or treatment with any investigational treatments for multiple sclerosis within the last year.
- •Any progressive form of MS.
- •Known Hypersensitivity to interferon beta 1a.
- •Inability to administer subcutaneous injections
- •Inability to undergo laboratory evaluation.
- •Seropositivity for HIV (by medical history)
- •Diabetes Mellitus Tyle I or II (by medical history)
- •Hepatitis B or C (by medical history)
- •Uncontrolled psychiatric disorder.
- •Any unstable illness that the investigator's opinion precludes participation in this study.
- •Inability to maintain compliance with study protocol.
- •Implanted devices or metal which would contraindicate MRI.
- •Clinically significant abnormalities in CBC or CMP
- •MMSE <25
结局指标
主要结局
Fasting leptin and nitric oxide testing
时间窗: monthly, for 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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