NCT06170970

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis Fatigue

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2023-12-14
• Last updated: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study