Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 60 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "This novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether solriamfetol helps reduce fatigue (strong tiredness) in adults ages 18 to 60 with multiple sclerosis (MS) and daytime sleepiness. Participants will take both the study drug and a placebo (a pill with no active drug) during separate treatment periods.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 60 years old and have stable health based on an exam, health history, and vital signs.
- Have MS confirmed by the study doctor using the 2024 McDonald diagnosis rules.
- Have fatigue as a main symptom, with a score of at least 33 on the MFIS fatigue survey.
- Score at least 10 on the ESS daytime sleepiness survey.
- Be able to walk at least 20 feet, with support on both sides if needed.
- Own an Android phone or iPhone, have internet and email access, and be able to use a computer, tablet, or smartphone.
- Agree to use a medically accepted birth control method during the study.
- Be willing and able to follow the study schedule and requirements and give written consent.
Who can't join
- Have a history of heart artery disease, heart failure, abnormal heart rhythms, stroke, or disease of the brain's blood vessels.
- Have uncontrolled high blood pressure (top number above 160 or bottom number above 100), or take treatments that raise blood pressure or heart rate.
- Have uncontrolled diabetes (last A1c above 7%), a body mass index (BMI) above 35, or high cholesterol (total above 240 mg/dL or LDL above 160 mg/dL).
- Have another medical or nerve condition linked to excessive sleepiness, or moderate or severe kidney problems (kidney filtering rate below 60 mL/min).
- Have phenylketonuria (trouble breaking down phenylalanine) or a reaction to a product made from phenylalanine; have a history of psychosis or bipolar disorder; or have alcohol or drug abuse within the past two years.
- Use products that make you more alert or sleepy, unless your dose has stayed the same for at least one month before screening and you agree to keep it the same during the study.
- Have used an MAO inhibitor drug within 14 days, or fatigue drugs within two weeks before screening, including amantadine, modafinil, armodafinil, or amphetamine-like stimulants.
- Be pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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 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)
Study sites (1)
MD
- Johns Hopkins University · Baltimore, MD 21287Mahsa Ghajarzadeh, MD, PhD · Study contact · 410-614-1522 · mghajar2@jhmi.eduLauren Vega, BSN · Study contact · 410-614-1522 · Ldimarc2@jhmi.eduMore trials in Baltimore