SOLARIMS

SOLARIMS — A Clinical Trial of Solriamfetol for MS Fatigue and Sleepiness

What Is This Study About?

The SOLARIMS study (IRB00295382) is a clinical trial being conducted at Johns Hopkins University. We are testing whether solriamfetol—a medication already approved by the FDA to treat excessive daytime sleepiness in people with narcolepsy and sleep apnea—can also reduce fatigue and daytime sleepiness in people with multiple sclerosis (MS).

Fatigue is the most common and one of the most disabling symptoms of MS. There is currently no FDA-approved medication for MS fatigue. The SOLARIMS study aims to help close this gap.

Who Can Join?

You may be eligible if:

  • You are between 18 and 60 years old
  • You have been diagnosed with MS (any type)
  • You experience significant fatigue as one of your main MS symptoms
  • You feel excessively sleepy during the day
  • You own an Android phone or iPhone
  • You are medically stable and able to walk at least 20 feet (with or without assistance)

You may NOT be eligible if you have certain heart conditions, uncontrolled high blood pressure or diabetes, a history of stroke, psychosis or bipolar disorder, or are currently taking stimulant medications for fatigue. A study team member will review your full eligibility.

What Does Participation Involve?

  • One in-person screening visit at Johns Hopkins Outpatient Center, Baltimore
  • A 10-day lead-in period (placebo, taken at home)
  • Two 4-week treatment periods: one with solriamfetol, one with placebo (the order is randomly assigned)
  • A 1-week washout period between the two treatment periods
  • One in-person visit at the end of each treatment period
  • Daily use of a smartphone app (Neurokeys) to passively and actively track fatigue during the study
  • Most questionnaires are completed online or by phone — from your home

What Are the Benefits of Joining?

  • All study medications and in-person visits are provided at no cost
  • $50 compensation for completing all study visits and procedures
  • Parking or transportation reimbursement for each in-person visit
  • You will help advance research into MS fatigue treatments

How Do I Sign Up or Learn More?

Contact the SOLARIMS study team:

About the Research Team

This study is led by Dr. Bardia Nourbakhsh, Associate Professor of Neurology and Associate Director of the Neuroimmunology Fellowship at Johns Hopkins University School of Medicine. Dr. Nourbakhsh has extensive experience in MS fatigue research and has led multiple clinical trials in this area.