Solriamfetol for Multiple Sclerosis Fatigue

(SOLARIMS Trial)

Overseen By Lauren Vega, BSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: MAO inhibitors, Stimulants

Disqualifiers: Coronary artery disease, Uncontrolled hypertension, Diabetes, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests solriamfetol, a medication aimed at reducing fatigue in people with Multiple Sclerosis (MS). Fatigue is a common issue for those with MS, and current treatments have not been effective. The study compares solriamfetol to a placebo (a pill with no active drug) to determine its effectiveness in reducing tiredness, particularly for those who feel very sleepy during the day. The trial seeks participants with MS who experience significant fatigue and excessive daytime sleepiness. Interested participants will need to use a smartphone to track their fatigue levels. As a Phase 2 trial, this research measures how well solriamfetol works in an initial, smaller group, offering a chance to contribute to potential new treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that solriamfetol is generally safe for use. In earlier studies, common side effects included headache and nausea, but these were mild and most participants tolerated them well. Long-term use of solriamfetol has led to significant improvements in daily life and work performance, helping individuals feel better and perform better at their jobs. Another study found that solriamfetol reduced tiredness and improved cognitive function in people with chronic fatigue syndrome. The treatment has proven safe and effective for various conditions, suggesting it is likely safe for treating fatigue in multiple sclerosis as well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MS fatigue?

Most treatments for multiple sclerosis (MS) fatigue, like amantadine or modafinil, work by stimulating the central nervous system or modifying neurotransmitter levels. But solriamfetol works differently, targeting dopamine and norepinephrine reuptake to enhance wakefulness and alertness. Researchers are excited about solriamfetol because it offers a new mechanism of action that could be more effective or better tolerated than existing options. Additionally, solriamfetol has shown potential for a rapid onset of action, which could provide quicker relief for those struggling with MS fatigue.

What evidence suggests that solriamfetol might be an effective treatment for multiple sclerosis fatigue?

Research shows that solriamfetol can reduce tiredness and improve cognitive function. In studies involving individuals with conditions like ME/CFS (chronic fatigue syndrome), solriamfetol outperformed a placebo after 6 to 8 weeks. This trial will assess solriamfetol's potential to alleviate MS-related tiredness. Participants will receive either solriamfetol followed by a placebo or a placebo followed by solriamfetol. Although direct evidence for its use in multiple sclerosis (MS) is limited, these results suggest it might help with MS-related tiredness, given the similarity of symptoms. The drug increases alertness, which could benefit those experiencing excessive daytime sleepiness along with fatigue. Its success in similar conditions offers hope for managing MS fatigue. ^{1 2 4 6 7}

Who Is on the Research Team?

Bardia Nourbakhsh, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Solriamfetol

Trial Overview 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.

How Is the Trial Designed?

Group I: solriamfetol then placebo first Experimental Treatment 2 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 first Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Axsome Therapeutics, Inc.

Industry Sponsor

Trials

34

Recruited

11,600+

Published Research Related to This Trial

In a pilot study involving 30 patients with relapsing-remitting multiple sclerosis, salbutamol did not show any significant improvement in fatigue levels compared to a placebo over a 90-day period.

While salbutamol was generally safe with no serious adverse events reported, it did not effectively reduce fatigue severity or improve other related measures, such as the Expanded Disability Status Scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does oral salbutamol improve fatigue in multiple sclerosis? A pilot placebo-controlled study. de Almeida, GM., Scola, RH., Ducci, RDP., et al.[2022]

In a study of 218 multiple sclerosis patients, those treated with glatiramer acetate showed a significantly higher improvement in fatigue levels compared to those treated with beta interferon, with 24.8% of glatiramer acetate patients improving versus 12.9% on beta interferon.

Glatiramer acetate not only improved overall fatigue but also showed better results in specific areas such as physical and cognitive fatigue, suggesting it may be a more effective option for managing fatigue in multiple sclerosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of immunomodulatory treatment on multiple sclerosis fatigue. Metz, LM., Patten, SB., Archibald, CJ., et al.[2022]

In a 9-week study involving 72 patients with multiple sclerosis, 200 mg/day of modafinil significantly improved fatigue levels compared to placebo, as measured by various fatigue scales.

The treatment was well tolerated, with no serious adverse events reported, although common side effects included headache and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study. Rammohan, KW., Rosenberg, JH., Lynn, DJ., et al.[2019]

The COMBO-MS trial is designed to compare the effectiveness of cognitive behavioral therapy (CBT), modafinil, and their combination in reducing fatigue in patients with multiple sclerosis (MS) over a 12-week period, involving random assignment of participants with significant fatigue.

The study aims to determine if combination therapy is more effective than either treatment alone and to explore how factors like depression, sleep disorders, and disease severity may influence treatment outcomes, which could lead to better management strategies for MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kratz, AL., Alschuler, KN., Ehde, DM., et al.[2020]

Fatigue is the most common and disabling symptom in multiple sclerosis (MS), affecting up to 40% of patients more than other symptoms like weakness or spasticity.

Imaging studies suggest that MS-related fatigue may be linked to reduced brain metabolism in specific areas, and while various treatments, including pharmacologic agents like modafinil, have been explored, the exact causes and effective interventions for this fatigue remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue associated with multiple sclerosis: diagnosis, impact and management. Bakshi, R.[2022]

Amantadine has been shown to be effective in reducing MS-related fatigue in about one-third of patients, making it a viable treatment option after ruling out secondary causes of fatigue.

Modafinil is the only medication that demonstrated significant efficacy compared to placebo on the Fatigue Severity Scale, indicating its potential as a reliable treatment for fatigue in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue in multiple sclerosis: a rational approach to evaluation and treatment. Rosenberg, JH., Shafor, R.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06170970?term=SOLRIAMFETOL&viewType=Table&rank=9

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a smartphone app that ...

2. ctv.veeva.com ctv.veeva.com/study/solriamfetol-for-the-treatment-of-multiple-sclerosis-fatigue

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913864/

A Comprehensive Review of Solriamfetol to Treat Excessive ... These results indicate the continued effectiveness of Solriamfetol, past the 12-week mark, which extends the known efficacy based on prior studies.

4. osf.io osf.io/j6v5t_v1/download/?format=pdf

Solriamfetol improves daily fatigue symptoms in adults with ... In this study, solriamfetol compared to placebo improved fatigue and cognitive symptoms after 6 and 8 weeks of treatment in adult patients with ME/CFS.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06170970?keyword=%22Sleepiness%22

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a smartphone app that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8494093/

Long-term effects of solriamfetol on quality of life and work ... Long-term solriamfetol treatment was associated with clinically meaningful, sustained improvements in functional status, work productivity, and quality of life ...

7. nationalmssociety-org.clinicaltrialconnect.com nationalmssociety-org.clinicaltrialconnect.com/trials/NCT06170970

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.