Testing solriamfetol for fatigue in people with multiple sclerosis

Trial details

Who runs it

Johns Hopkins University

Trial code

NCT06170970

Record updated

9 June 2026

Original description

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.Read full original descriptionShow less

Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness

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.

Inclusion: 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.

Exclusion: Receiving drugs/treatments that increase blood pressure or heart rate (based on the PI review of the medications/treatments); 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; 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; 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 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; A known history of moderate or severe kidney dysfunction (estimated Glomerular filtration rate of less than 60 mL/min); 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); Pregnant or lactating.

ClinicalTrials.gov NCT06170970