Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Launched by JOHNS HOPKINS UNIVERSITY · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Solriamfetol to see if it can help reduce fatigue in people with Multiple Sclerosis (MS). Fatigue is a major issue for many MS patients, affecting up to 90% of them, and current treatments aren’t very effective. The trial involves participants taking either the medication or a placebo (which looks the same but has no active ingredients) over several weeks. Participants will track their fatigue levels using a special smartphone app, which aims to provide real-time updates on their condition.

To be eligible for this study, participants need to be between 18 and 60 years old, have a confirmed diagnosis of MS, and experience significant fatigue. They should also be able to walk short distances, have access to the internet, and be comfortable using a smartphone or tablet. During the trial, participants will need to follow a specific schedule and provide written consent to take part. It’s important to note that certain health conditions or medications may exclude individuals from participating to ensure their safety during the study.

Gender

ALL

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 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
• 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)