No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 60 who have multiple sclerosis and experience significant fatigue. Participants will try a medication or placebo for a short time and share their experiences with fatigue using an app.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old.
I have been diagnosed with multiple sclerosis.
I often feel fatigued and score 33 or more on the MFIS test.
I score 10 or more on the ESS test.
I can walk at least 20 feet with help.
I have access to the internet and can use a computer or smartphone.
I will use contraception during the study.
I can provide written consent.
You may not be able to join if
I have a history of heart disease or heart failure.
I have uncontrolled high blood pressure.
I have uncontrolled diabetes or a high BMI.
I have had a stroke or cerebrovascular disease.
I have a medical condition that causes excessive sleepiness besides MS.
I have had substance abuse issues in the past two years.
I am pregnant or breastfeeding.
I have kidney dysfunction.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-bli…
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.
Trial Locations
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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 f…
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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