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Solriamfetol for Multiple Sclerosis Fatigue

This study is testing Solriamfetol to see if it can help with fatigue in people who have Multiple Sclerosis (MS). Solriamfetol is a drug that will be given as a pill, starting at 75 mg daily for three days, then increasing to 150 mg daily for the rest of the four-week treatment period. Some participants will receive a placebo (an inactive pill) instead. The study is looking to see if Solriamfetol can improve fatigue, measured by a score called the Modified Fatigue Impact Scale (MFIS). You may be able to join if you are between 18 and 60 years old, have MS, and experience fatigue as a main symptom with an MFIS score of 33 or more. The current status of this study is unclear, and it plans to enroll 46 participants.

Study design
This is a randomized, double-blind, placebo-controlled crossover study, meaning participants will randomly receive either Solriamfetol or a placebo without knowing which one they are getting. The study plans to enroll 46 participants.
What's involved
Participants will have a 10-day lead-in period, followed by two four-week treatment periods, with a one-week break (washout) in between. Fatigue will be measured using the Modified Fatigue Impact Scale and a smartphone app.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be measured for up to 4 weeks after starting treatment.

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NCT06170970

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Recruiting
PHASE2Ages 18–60InterventionalTreatment
Johns Hopkins University
~46 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:SolriamfetolPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Modified Fatigue Impact Scale (MFIS) Score
Measured over Up to 4 weeks

Conditions

Multiple Sclerosis
Multiple Sclerosis Fatigue

Explore related trials

Multiple Sclerosis

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Bardia Nourbakhsh, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

Who to contact

Lauren Vega, BSN
[email protected]
410-614-1522
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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)

What this trial measures

  • Modified Fatigue Impact Scale (MFIS) ScoreUp 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.