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RECRUITING
NCT06170970
PHASE2

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-06-01

Completion Date

2027-03-01

Last Updated

2025-06-11

Healthy Volunteers

No

Interventions

DRUG

Solriamfetol

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)

DRUG

Placebo

Four weeks of oral placebo

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States