Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

NCT ID: NCT06170970

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-03-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

solriamfetol then placebo first

Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo

Group Type: EXPERIMENTAL

Solriamfetol

Intervention Type: DRUG

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

Intervention Type: DRUG

Four weeks of oral placebo

placebo then solriamfetol first

Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol

Group Type: EXPERIMENTAL

Solriamfetol

Intervention Type: DRUG

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

Intervention Type: DRUG

Four weeks of oral placebo

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)

Intervention Type: DRUG

Placebo

Four weeks of oral placebo

Intervention Type: DRUG

Other Intervention Names

Sunosi

Eligibility Criteria

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 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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bardia Nourbakhsh, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mahsa Ghajarzadeh, MD,PhD

Role: CONTACT

mghajar2@jhmi.edu

410-614-1522

Lauren Vega, BSN

Role: CONTACT

ldimarc2@jhmi.edu

410-614-1522

Facility Contacts

Mahsa Ghajarzadeh, MD, PhD

Role: primary

mghajar2@jhmi.edu

410-614-1522

Lauren Vega, BSN

Role: backup

Ldimarc2@jhmi.edu

410-614-1522

Other Identifiers

IRB00295382

Identifier Type: -

Identifier Source: org_study_id