Solriamfetol for Multiple Sclerosis Fatigue
(SOLARIMS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byBardia Nourbakhsh, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: MAO inhibitors, Stimulants
Disqualifiers: Coronary artery disease, Uncontrolled hypertension, Diabetes, Psychosis, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop using medications for fatigue, like amantadine or modafinil, at least two weeks before the screening. If you're on medications that affect blood pressure or heart rate, you may need to stop those too. However, if you're on a steady dose of a stimulating or sedating product for at least a month, you can continue using it during the study.
What data supports the effectiveness of the drug Solriamfetol for treating fatigue in multiple sclerosis?
While there is no direct evidence for Solriamfetol in treating multiple sclerosis fatigue, similar drugs like modafinil have shown effectiveness in reducing fatigue in MS patients. Modafinil, a wake-promoting agent, has been effective in clinical trials, suggesting that Solriamfetol, which has similar properties, might also help.
12345How does the drug Solriamfetol differ from other treatments for multiple sclerosis fatigue?
Solriamfetol is unique because it is a wake-promoting agent that works by increasing dopamine and norepinephrine levels in the brain, which is different from other treatments like modafinil or amantadine that have been traditionally used for MS-related fatigue. This mechanism may offer a novel approach to managing fatigue in multiple sclerosis.
23456Eligibility Criteria
This trial is for adults aged 18-60 with Multiple Sclerosis who suffer from fatigue, can walk at least 20 feet (even with help), and have internet access. They must be medically stable and use contraception during the study. Those without a smartphone or outside the age range cannot join.Inclusion Criteria
Must meet McDonald 2017 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
A screening ESS score of 10 or more
Must have internet and email access and the ability to use a computer or tablet, or smartphone
+8 more
Exclusion Criteria
I have uncontrolled diabetes, a BMI over 35, or very high cholesterol.
I have a history of irregular heartbeats.
A history of alcohol or drug abuse within the past two years
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Lead-in
Participants undergo a 10-day lead-in with the medication/placebo
10 days
Treatment Period 1
Participants receive four weeks of treatment with solriamfetol or placebo
4 weeks
Washout
One week washout period between treatment phases
1 week
Treatment Period 2
Participants receive four weeks of treatment with the alternate medication (solriamfetol or placebo)
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests Solriamfetol against a placebo to treat MS-related fatigue. Participants will take either the drug or placebo across two four-week periods, separated by one week off, to see if there's an improvement in their fatigue levels measured by MFIS.
2Treatment groups
Experimental Treatment
Group I: solriamfetol then placebo firstExperimental Treatment2 Interventions
Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo
Group II: placebo then solriamfetol firstExperimental Treatment2 Interventions
Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol
Solriamfetol is already approved in United States for the following indications:
🇺🇸 Approved in United States as Sunosi for:
- Excessive daytime sleepiness in patients with narcolepsy
- Excessive daytime sleepiness in patients with obstructive sleep apnea
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins UniversityBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Multiple Sclerosis SocietyCollaborator
Axsome Therapeutics, Inc.Industry Sponsor
References
The effect of immunomodulatory treatment on multiple sclerosis fatigue. [2022]To assess the effects of glatiramer acetate and beta interferon on fatigue in multiple sclerosis.
A randomized pragmatic trial of telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy of both for fatigue in multiple sclerosis: The design of the "COMBO-MS" trial. [2020]Fatigue is one of the most common and disabling chronic symptoms in multiple sclerosis (MS). Optimization of available treatments for MS-related fatigue has been stymied by lack of comparative effectiveness research that focuses on real-world treatment delivery methods and potential modification of treatment effect by other chronic MS symptoms or disability level. This report describes the design of a patient centered, comparative effectiveness trial of cognitive behavioral-therapy (CBT), modafinil, and combination therapy of both for fatigue in MS ("COMBO-MS").
Fatigue in multiple sclerosis: a rational approach to evaluation and treatment. [2019]With the publication of the Multiple Sclerosis Council Guideline on the management of multiple sclerosis (MS) fatigue, there has been increased appreciation for the role fatigue can play in MS. Secondary fatigue is fatigue caused by other etiologies than those directly related to MS. Once these causes are ruled out, fatigue is related to MS. Secondary MS-related fatigue comes as result of the symptoms of MS that drain energy. Once secondary MS causes are ruled out, then the patient is deemed as having primary MS fatigue. Fatigue management is both nonpharmacologic and pharmacologic. Occupational therapists are the major allied health providers that address the role fatigue plays in MS patients. Over the past two decades, numerous clinical trials have been conducted on drugs for treating MS-related fatigue. Of these agents, amantadine has been studied for the longest period, and has shown efficacy in about one third of patients with MS-related fatigue on several commonly used scales. Two randomized -trials of the central nervous system stimulant pemoline have yielded unimpressive results; efficacy was seen at higher doses but coupled with an unacceptable risk of adverse events. The wake-promoting agent modafinil is the only agent to show efficacy compared with placebo on the Fatigue Severity Scale, a measure that is highly resistant to "impulse answering" and is thus viewed as one of the most difficult scales on which to show -benefit. This article reviews fatigue in MS and proposes a rational strategy for evaluation and management of this most common MS symptom.
Does oral salbutamol improve fatigue in multiple sclerosis? A pilot placebo-controlled study. [2022]Because MS-related fatigue could be associated with enhanced proinflammatory cytokine production, drugs with immunomodulatories properties, such as salbutamol, may represent an alternative treatment. We aimed to evaluate the effect of salbutamol on MS-related fatigue.
Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study. [2019]To assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis (MS).
Fatigue associated with multiple sclerosis: diagnosis, impact and management. [2022]In patients with multiple sclerosis (MS) fatigue is the most common symptom and one of the most disabling features. As many as 40% have described it as the single most disabling symptom--a higher percentage than weakness, spasticity, motor problems, or bowel or bladder problems. The etiology and pathophysiology of MS-related fatigue remain unknown. Studies have failed to demonstrate an association between MS-related fatigue and the level of disability, clinical disease subtype, or gender, although recent data show an association between MS-related fatigue and depression and quality of life. Imaging studies using positron emission tomography suggest that fatigue in MS is related to hypometabolism of specific brain areas, including the frontal and subcortical circuits. The impact of fatigue on patient functioning and quality of life clearly warrants intervention. In addition to nonpharmacologic measures, such as exercise and energy conservation strategies, several pharmacologic agents have been evaluated for their ability to reduce MS-related fatigue, including amantadine, central nervous system stimulants (pemoline), and the novel wake-promoting agent modafinil.