Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale
研究概览
简要总结
The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.
详细描述
ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative care, including symptom management, can contribute greatly to improved quality of life. In this context, alleviation of fatigue can help maintain function, extend the duration of time when employment is feasible for those still working, and can enable patients to more fully participate in and enjoy social and recreational activities. Given the prevalence of fatigue in this population, identification of effective treatment is a meaningful goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of ALS
- •Ages 18-80
- •Clinically significant fatigue (4.5+ on Fatigue Severity Scale with duration 3+ months plus impairment in 1+ categories of role function)
- •Speaks English
- •Able and willing to give informed consent
- •Can communicate verbally or with assistive device
- •Can swallow capsules
- •Forced vital capacity 50+%
排除标准
- •Untreated hypothyroidism (TSH > 4.25 UIU/ML)
- •Untreated and uncontrolled hypertension
- •Clinically significant anemia (HCT < 33%)
- •Untreated or under-treated major depressive disorder
- •Current clinically significant suicidal ideation
- •Started antidepressant medication for treatment of depression during past 6 weeks
- •Currently taking psychostimulant medication
- •History or current psychosis or bipolar disorder
- •Fecund women not currently using barrier methods of contraception
研究组 & 干预措施
Modafinil
Eligible patients will be treated at baseline through Week 4. Those who choose to continue will have additional in-person visits at Weeks 8 and 12 visits (and Week 16 for those starting modafinil at Week 4).
干预措施: Modafinil (Drug)
Placebo
Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.
干预措施: Placebo (Drug)
结局指标
主要结局
Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale
时间窗: 4 weeks
The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying "responder" and all the rest as "non-responder" using all available data including clinician judgement, and ratings scales.
次要结局
- Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery(4 weeks)