Using Solriamfetol to treat fatigue in Multiple Sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of Solriamfetol, a wake-promoting agent, in alleviating fatigue in patients with Multiple Sclerosis (MS). The study employs a randomized, double-blind, placebo-controlled crossover design, where participants will receive either the medication or a placebo over two four-week treatment periods, separated by a washout week. Fatigue levels will be primarily assessed using the Modified Fatigue Impact Scale (MFIS), alongside innovative real-time measurements through a smartphone app. This approach aims to provide a more detailed understanding of fatigue fluctuations in MS patients.

Why it matters

Who can join: the full rules

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)

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Bardia Nourbakhsh, MD — Johns Hopkins School of Medicine
• Study coordinator: Lauren Vega, BSN
• Email: Ldimarc2@jhmi.edu
• Phone: 410-614-1522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.