A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Modified Fatigue Impact Scale (MFIS)
研究概览
简要总结
Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are limited. Several studies have shown that a large proportion of men with MS have low testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a treatment for MS-related fatigue in men with progressive MS who have low or low-normal testosterone levels.
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
盲法说明
All patients will receive either testosterone or placebo at some phase of treatment, but which phase will be testosterone and which will be placebo will be unknown (blinded) to participant, care provider, and outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with SPMS or PPMS, 2)18-60 years old, 3) EDSS of 1.0- 6.5, 4) Low or low-normal T < 499ng/dL and 5) FSS scores of >3.6.
排除标准
- •Prostate specific antigen > 2.5 (<49yr of age) or >3.5 (age >50yr of age), 2) baseline hematocrit greater than the upper limit of normal for the laboratory used, 3) EKG with ischemic changes, 4) history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis, 5) history of prostate or breast cancer, 6) screening T level >500ng/dL, 7) diabetes requiring treatment, 8) current drug/alcohol abuse, 9) disease other than MS causing fatigue, such as obstructive sleep apnea or other sleep disorder, or untreated thyroid dysfunction, 10) RRMS, 11) Beck Depression Inventory-II (BDI) score over 20, 12) cognitive dysfunction such that subject cannot perform study tests, 13) inability to undergo MRI, 14) current or expected use of amphetamines, or 15) anticipated changes in medical treatments that might affect fatigue scores (e.g., expected changes in spasticity, sleep, or depression medications).
研究组 & 干预措施
Single arm crossover
All patients will receive testosterone gel and placebo gel during some months, but the months that they are on each treatment will be unknown to the patient
干预措施: AndroGel 1 % Topical Gel (Drug)
Single arm crossover
All patients will receive testosterone gel and placebo gel during some months, but the months that they are on each treatment will be unknown to the patient
干预措施: Placebos (Drug)
结局指标
主要结局
Modified Fatigue Impact Scale (MFIS)
时间窗: 18 months
assessment of fatigue severity
次要结局
- Localized Gray Matter Atrophy(18 months)
- Axon Density in White Matter(18 months)
研究者
Rhonda Voskuhl
Professor, Department of Neurology
University of California, Los Angeles