RECRUITING

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Conditions

Multiple Sclerosis Multiple Sclerosis Fatigue fatigue daytime sleepiness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-01

Study Completion:2027-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06170970

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

Mahsa Ghajarzadeh, MD,PhD

CONTACT

410-614-1522

mghajar2@jhmi.edu

Lauren Vega, BSN

CONTACT

410-614-1522

ldimarc2@jhmi.edu

Principal Investigator

Bardia Nourbakhsh, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01

Study Completion Date2027-03-01

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

multiple sclerosis
fatigue
daytime sleepiness

Additional Relevant MeSH Terms

Multiple Sclerosis
Multiple Sclerosis Fatigue