Status:
RECRUITING
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Multiple Sclerosis Society
Axsome Therapeutics, Inc.
Conditions:
Multiple Sclerosis
Multiple Sclerosis Fatigue
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 lim...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06170970
Start Date
June 1 2024
End Date
March 1 2027
Last Update
June 11 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287