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Solriamfetol for the Treatment of Multiple Sclerosis Fatigue — SOLARIMS  

Multiple Sclerosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06170970
Study type Interventional
Source Johns Hopkins University
Contact Mahsa Ghajarzadeh, MD,PhD
Phone 410-614-1522
Email mghajar2@jhmi.edu
Status Recruiting
Phase Phase 2
Start date June 1, 2024
Completion date March 1, 2027
View Details
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