Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the medication Baclofen for treatment of muscle cramps in patients with cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis
- •Presence of muscle cramps on a regular basis
排除标准
- •Allergy or hypersensitivity to Baclofen
- •Active or untreated Portosystemic encephalopathy
- •Active alcohol or substance abuse
- •Age less than 18
- •Pregnancy
- •Concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent
- •Concomitant use of Tricyclic Antidepressant due to drug interaction
- •History of chronic kidney disease defined by GFR < 30 (using MDRD equation)
- •Subject is institutionalized or a prisoner
- •Inability or unwillingness to give informed consent
- •Expected lifespan less than 3 months
- •Severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols
研究组 & 干预措施
Treatment
All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
干预措施: Baclofen (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)
时间窗: 4 weeks of active therapy
Proportion of patients with nausea at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)
时间窗: 4 weeks of active therapy
Proportion of patients with somnolence at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)
时间窗: 4 weeks of active therapy
Proportion of patients with headache at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)
时间窗: 4 weeks of active therapy
Proportion of patients with endephalopathy at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)
时间窗: 4 weeks of active therapy
Proportion of patients with dizziness at any time during the 4 weeks of therapy
次要结局
- Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy(Baseline to 4 weeks of therapy)
- Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy(Baseline to end of 4 weeks of therapy)
- Change in Frequency of Muscle Cramps After Washout Period(End of treatment (week 4) to end of washout (week 7))
- Change in Severity of Muscle Cramps After Washout Period(End of treatment (week 4) to end of washout (week 7))
研究者
Zachary Henry, MD
Fellow Physician
University of Virginia