Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

NCT06170970 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00295382
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

multiple sclerosis; fatigue; daytime sleepiness

Outcome Measures

Primary Outcomes (1)

• Modified Fatigue Impact Scale (MFIS) Score

  MFIS score measured during the last three days of each 4-week medication period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.

  Up to 4 weeks

Secondary Outcomes (2)

• Fatigue Severity Scale (FSS) Score

  Up to 4 weeks

• Epworth Sleepiness Scale (ESS) Score

  Up to 4 weeks

Study Arms (2)

solriamfetol then placebo first

EXPERIMENTAL

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

Drug: Solriamfetol; Drug: Placebo

placebo then solriamfetol first

EXPERIMENTAL

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

Drug: Solriamfetol; Drug: Placebo

Interventions

Solriamfetol 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)

Also known as: Sunosi

placebo then solriamfetol first; solriamfetol then placebo first

Placebo DRUG

Four weeks of oral placebo

placebo then solriamfetol first; solriamfetol then placebo first

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Multiple Sclerosis Society: collaborator
• Axsome Therapeutics, Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Disorders of Excessive Somnolence

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Bardia Nourbakhsh, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahsa Ghajarzadeh, MD,PhD

CONTACT

410-614-1522; mghajar2@jhmi.edu

Lauren Vega, BSN

CONTACT

410-614-1522; ldimarc2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one year after the publication of the main trial results to 5 years after the publication.
• Access Criteria: Researchers accessing the data must agree to terms that uphold privacy, ensure data security, and prohibit the further sharing of data with third parties.

Locations

US (1)