RecruitingPhase 2NCT06170970

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness

Sponsor

Johns Hopkins University

Enrollment

46 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis Multiple Sclerosis Fatigue

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 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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether solriamfetol — a drug currently approved to treat excessive sleepiness — can reduce fatigue and daytime sleepiness in people with multiple sclerosis (MS), which is a common and disabling symptom. **You may be eligible if...** - You are 18 to 60 years old and have been diagnosed with multiple sclerosis (MS) meeting standard diagnostic criteria - Fatigue is one of your main symptoms, with a score of 33 or higher on a fatigue scale - You score 10 or higher on a daytime sleepiness scale - You can walk at least 20 feet, even with assistance - You have a smartphone (iPhone or Android) and internet access **You may NOT be eligible if...** - You have coronary artery disease or heart failure - You have uncontrolled high blood pressure (above 160/100) - You have uncontrolled diabetes, high cholesterol, or a BMI above 35 - You take medications that raise blood pressure or heart rate - You have a history of stroke or cerebrovascular disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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