Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Status:
Recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Axsome Therapeutics, Inc. National Multiple Sclerosis Society