Could a wakefulness drug tame MS fatigue?
NCT ID NCT06170970
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether solriamfetol (Sunosi), a drug used for sleepiness, can reduce fatigue in people with multiple sclerosis who also have excessive daytime sleepiness. About 46 participants will receive either the drug or a placebo for four weeks, then switch after a washout period. The study uses a smartphone app to track fatigue through typing patterns, aiming for more precise measurements.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Solriamfetol (Sunosi)
- What this could lead to
- If it works, this could offer a new treatment option for fatigue in people with multiple sclerosis who also have excessive daytime sleepiness.
- What could go wrong
- This is a small, early-phase trial (46 people) and may not show clear benefit. Fatigue is complex, and results may not apply to everyone with MS.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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