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New treatment option for Multiple Sclerosis
Official title Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
ClinicalTrials.gov ID: NCT06170970
What this study is testing
What is Solriamfetol?
Solriamfetol is an investigational medicine, given as an once-daily, being studied as a potential treatment for multiple sclerosis.
Also referred to as Sunosi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.
See the full 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 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.