Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Description

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

Multiple Sclerosis, Multiple Sclerosis Fatigue

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Study Overview

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Study Details

Study overview

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.

Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 2017 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
  • * 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)

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Bardia Nourbakhsh, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

2027-03-01