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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

• Own an android smartphone or an iphone

• Consent to use a medically acceptable method of contraception for the duration of the study

• Willing and able to comply with the study design schedule and other requirements

• Willing and able to provide written informed consent

Locations
United States
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Mahsa Ghajarzadeh, MD,PhD
mghajar2@jhmi.edu
410-614-1522
Backup
Lauren Vega, BSN
ldimarc2@jhmi.edu
410-614-1522
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 46
Treatments
Experimental: solriamfetol then placebo first
Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo
Experimental: placebo then solriamfetol first
Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol
Sponsors
Collaborators: Axsome Therapeutics, Inc., National Multiple Sclerosis Society
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov