Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

• Status: Recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Axsome Therapeutics, Inc.; National Multiple Sclerosis Society

Criteria

Inclusion Criteria:

• 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 2017 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 Criteria:

• 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)