Clinical trial NCT06170970: Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Official title: Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Multiple Sclerosis Fatigue
Keywords: multiple sclerosis
fatigue
daytime sleepiness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Axsome Therapeutics, Inc.
First posted: 2023-12-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Modified Fatigue Impact Scale (MFIS) Score
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Fatigue Severity Scale (FSS) Score
timeFrame: Up to 4 weeks
measure: Epworth Sleepiness Scale (ESS) Score
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Bardia Nourbakhsh, MD
role: PRINCIPAL_INVESTIGATOR
References: