Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Modified Fatigue Impact Scale (MFIS) Score
研究概览
简要总结
Fatigue is a prevalent and disabling symptom in Multiple Sclerosis (MS), affecting up to 90% of patients. Current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness. Previous research indicates that these agents may be beneficial specifically for MS patients with concomitant excessive daytime sleepiness. This study uses a randomized, double-blind, placebo-controlled crossover design. Participants will undergo a 10-day lead-in with he medication/placebo, followed by two four-week treatment periods separated by a one-week washout. Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a smartphone app that assesses fatigue through keystroke dynamics. This novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 60 years of age, inclusive.
- •Medically stable on the basis of physical examination, medical history, and vital signs
- •Must meet McDonald 2024 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
- •Must complain from fatigue as one of their main symptoms and have a screening MFIS score of 33 or more
- •A screening ESS score of 10 or more
- •Must be ambulatory (able to walk at least 20 feet using bilateral assistance)
- •Must have internet and email access and the ability to use a computer or tablet, or smartphone
- •Own an android smartphone or an iphone
- •Consent to use a medically acceptable method of contraception for the duration of the study
- •Willing and able to comply with the study design schedule and other requirements
- •Willing and able to provide written informed consent
排除标准
- •History of coronary artery disease or congestive heart failure
- •Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100)
- •A known history of uncontrolled diabetes (the last known hemoglobin A1c level above 7.0%), high BMI (>35), or hyperlipidemia (last known total cholesterol >240 mg/dl, or LDL cholesterol level >160 mg/dl)
- •Receiving drugs/treatments that increase blood pressure or heart rate (based on the PI review of the medications/treatments)
- •A history of cerebrovascular disease or stroke
- •A medical or neurological disorder other than MS, that was associated with excessive sleepiness.
- •A history of phenylketonuria or hypersensitivity to the phenylalanine-derived product
- •A history of alcohol or drug abuse within the past two years
- •A history of psychosis, or bipolar disorder
- •A history of cardiac arrythmias
- •The use of any product with stimulating or sedating properties, unless they have been on a steady dose for at least a month prior to the screening visit and agree to stay on the same dose over the course of the study
- •Use within 14 days of a monoamine oxidase (MAO) inhibitor drug
- •Pregnant or lactating
- •Use of medications used for the treatment of fatigue (including amantadine, modafinil, armodafinil, and amphetamine-like stimulants) in the past two weeks of the screening visit
- •A known history of moderate or severe kidney dysfunction (estimated Glomerular filtration rate of less than 60 mL/min)
研究组 & 干预措施
solriamfetol then placebo first
Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo
干预措施: Solriamfetol (Drug)
solriamfetol then placebo first
Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo
干预措施: Placebo (Drug)
placebo then solriamfetol first
Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol
干预措施: Placebo (Drug)
placebo then solriamfetol first
Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol
干预措施: Solriamfetol (Drug)
结局指标
主要结局
Modified Fatigue Impact Scale (MFIS) Score
时间窗: Up to 4 weeks
MFIS score measured during the last three days of each 4-week medication period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
次要结局
- Fatigue Severity Scale (FSS) Score(Up to 4 weeks)
- Epworth Sleepiness Scale (ESS) Score(Up to 4 weeks)