Actively Recruiting
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Led by Johns Hopkins University · Updated on 2025-06-11
46
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Multiple Sclerosis Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 to 60 years of age, inclusive
- Medically stable based on physical exam, medical history, and vital signs
- Meet McDonald 2017 criteria for multiple sclerosis diagnosis
- Report fatigue as a main symptom with a Modified Fatigue Impact Scale (MFIS) score of 33 or more
- Have an Epworth Sleepiness Scale (ESS) score of 10 or more
- Able to walk at least 20 feet using bilateral assistance
- Have internet and email access and can use a computer, tablet, or smartphone
- Own an Android or iPhone smartphone
- Agree to use medically acceptable contraception during the study
- Willing and able to follow the study schedule and requirements
- Able to provide written informed consent
You will not qualify if you...
- History of coronary artery disease or congestive heart failure
- Uncontrolled high blood pressure (systolic >160 or diastolic >100) at screening
- History of uncontrolled diabetes (HbA1c >7.0%), high BMI (>35), or high cholesterol levels (total cholesterol >240 mg/dl or LDL >160 mg/dl)
- Receiving treatments that raise blood pressure or heart rate
- History of stroke or cerebrovascular disease
- Medical or neurological disorders other than MS associated with excessive sleepiness
- History of phenylketonuria or sensitivity to phenylalanine-derived products
- History of alcohol or drug abuse in the past two years
- History of psychosis or bipolar disorder
- History of cardiac arrhythmias
- Use of stimulating or sedating products unless on a stable dose for at least one month prior to screening and agreeing to maintain that dose
- Use of monoamine oxidase (MAO) inhibitors within 14 days
- Pregnant or breastfeeding
- Use of fatigue treatment medications (amantadine, modafinil, armodafinil, amphetamine-like stimulants) within two weeks prior to screening
- Known moderate or severe kidney dysfunction (estimated glomerular filtration rate less than 60 mL/min)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
M
Mahsa Ghajarzadeh, MD,PhD
CONTACT
L
Lauren Vega, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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