Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study
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
- Determine the threshold dose 20 or 40 mg/d of baclofen and the dose-response curve of the medication for its effect to raise plasma IGF-1 levels
研究概览
简要总结
Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce growth hormone. Growth hormone is important for muscle tissue as well as many other tissues in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I levels. IGF-I levels will be determined before and after treatment with baclofen. In this study, the investigators will determine the minimum dose of baclofen at which improvements in GH and IGF-1 levels occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic SCI (injury greater than 6 months) who have been screened and found to have depressed plasma IGF-1 levels and who are not taking baclofen.
排除标准
- •Acute illness of any etiology,
- •Patients with chronic renal, liver, lung, or cardiac disease,
- •Patients receiving any of the following medications: narcotics, or L-DOPA, and
- •Alcoholics.
研究组 & 干预措施
1
Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.
干预措施: Baclofen (Drug)
结局指标
主要结局
Determine the threshold dose 20 or 40 mg/d of baclofen and the dose-response curve of the medication for its effect to raise plasma IGF-1 levels
时间窗: 20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy
次要结局
- Assessment of the adverse side effects, if any, of low dose baclofen therapy(20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy)