Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

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)