Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
Johns Hopkins University
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
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugSolriamfetol
solriamfetol 75 mg daily for 3 days and will increase the dose to 150 mg daily starting on day 4 of the treatment period (total of four weeks)
- DrugPlacebo
Four weeks of oral placebo
Location
- Johns Hopkins UniversityBaltimore, Maryland