Recruiting
Phase 2

Solriamfetol

Sponsor:

Johns Hopkins University

Code:

NCT06170970

Conditions

Multiple Sclerosis

Multiple Sclerosis Fatigue

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Solriamfetol

Placebo

Study Details

Brief 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

Study ID

NCT06170970

Start date

Jun 1, 2024

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 2024 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

Exclusion Criteria:

  • History of coronary artery disease or congestive heart failure
  • Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100)
  • A known history of uncontrolled diabetes (the last known hemoglobin A1c level above 7.0%), high BMI (>35), or hyperlipidemia (last known total cholesterol >240 mg/dl, or LDL cholesterol level >160 mg/dl)
  • Receiving drugs/treatments that increase blood pressure or heart rate (based on the PI review of the medications/treatments)
  • A history of cerebrovascular disease or stroke
  • A medical or neurological disorder other than MS, that was associated with excessive sleepiness.
  • A history of phenylketonuria or hypersensitivity to the phenylalanine-derived product
  • A history of alcohol or drug abuse within the past two years
  • A history of psychosis, or bipolar disorder
  • A history of cardiac arrythmias
  • The use of any product with stimulating or sedating properties, unless they have been on a steady dose for at least a month prior to the screening visit and agree to stay on the same dose over the course of the study
  • Use within 14 days of a monoamine oxidase (MAO) inhibitor drug
  • Pregnant or lactating
  • Use of medications used for the treatment of fatigue (including amantadine, modafinil, armodafinil, and amphetamine-like stimulants) in the past two weeks of the screening visit
  • A known history of moderate or severe kidney dysfunction (estimated Glomerular filtration rate of less than 60 mL/min)

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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)

Placebo

Four weeks of oral placebo

Primary outcome measure

  • Modified Fatigue Impact Scale (MFIS) Score [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Central contacts

Lauren Vega, BSN

410-614-1522Ldimarc2@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Mahsa Ghajarzadeh, MD, PhD

410-614-1522mghajar2@jhmi.edu

Lauren Vega, BSN

410-614-1522Ldimarc2@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • multiple sclerosis
  • fatigue
  • daytime sleepiness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-09.