Multiple Sclerosis Clinical Trial
— SOLARIMSOfficial title:
Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | March 1, 2027 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Axsome Therapeutics, Inc., National Multiple Sclerosis Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Fatigue Impact Scale (MFIS) Score | MFIS score measured during the last three days of each 4-week medication period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue. | Up to 4 weeks | |
Secondary | Fatigue Severity Scale (FSS) Score | FSS score measured during the last three days of each 4-week medication period. The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue. | Up to 4 weeks | |
Secondary | Epworth Sleepiness Scale (ESS) Score | ESS score measured during the last three days of each 4-week medication period. The total score of the ESS ranges from 0 to 24. Higher scores denote more severe daytime sleepiness. | Up to 4 weeks |
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