Using Solriamfetol to treat fatigue in Multiple Sclerosis
Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
PHASE2 · Johns Hopkins University · NCT06170970
This study is testing if a new medication called Solriamfetol can help reduce fatigue in people with Multiple Sclerosis.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06170970 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Solriamfetol, a wake-promoting agent, in alleviating fatigue in patients with Multiple Sclerosis (MS). The study employs a randomized, double-blind, placebo-controlled crossover design, where participants will receive either the medication or a placebo over two four-week treatment periods, separated by a washout week. Fatigue levels will be primarily assessed using the Modified Fatigue Impact Scale (MFIS), alongside innovative real-time measurements through a smartphone app. This approach aims to provide a more detailed understanding of fatigue fluctuations in MS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a confirmed diagnosis of Multiple Sclerosis who experience significant fatigue.
Not a fit: Patients with a history of coronary artery disease or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from fatigue related to Multiple Sclerosis.
How similar studies have performed: Previous studies have shown limited effectiveness of current treatments for MS-related fatigue, making this approach novel and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Bardia Nourbakhsh, MD — Johns Hopkins School of Medicine
- Study coordinator: Mahsa Ghajarzadeh, MD,PhD
- Email: mghajar2@jhmi.edu
- Phone: 410-614-1522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Multiple Sclerosis Fatigue, multiple sclerosis, fatigue, daytime sleepiness