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Wake-promoting Agent
Solriamfetol for Multiple Sclerosis Fatigue (SOLARIMS Trial)
Phase 2
Recruiting
Led By Bardia Nourbakhsh, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must complain from fatigue as one of their main symptoms and have a screening MFIS score of 33 or more
Must be ambulatory (able to walk at least 20 feet using bilateral assistance)
Must not have
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)
A known history of moderate or severe kidney dysfunction (estimated Glomerular filtration rate of less than 60 mL/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Summary
"This trial aims to study fatigue in Multiple Sclerosis patients. Current treatments are not very effective, so the study will test a new medication on patients with excessive daytime sleepiness. The study will be double
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, Solriamfetol may generally cause headache, nausea, insomnia, anxiety, and increased heart rate based on its action as a wake-promoting agent.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel very tired and my fatigue score is 33 or higher.
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I can walk at least 20 feet with some help.
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I am between 18 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have uncontrolled diabetes, a BMI over 35, or very high cholesterol.
Select...
I have moderate to severe kidney problems.
Select...
I have a history of heart disease or heart failure.
Select...
I have a history of irregular heartbeats.
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I have had a stroke or cerebrovascular disease in the past.
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I do not have uncontrolled high blood pressure.
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I have a condition besides MS that makes me very sleepy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Modified Fatigue Impact Scale (MFIS) Score
Secondary study objectives
Epworth Sleepiness Scale (ESS) Score
Fatigue Severity Scale (FSS) Score
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solriamfetol
2021
Completed Phase 4
~60
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,720 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
2,522 Patients Enrolled for Multiple Sclerosis
National Multiple Sclerosis SocietyOTHER
98 Previous Clinical Trials
10,518 Total Patients Enrolled
96 Trials studying Multiple Sclerosis
10,164 Patients Enrolled for Multiple Sclerosis
Axsome Therapeutics, Inc.Industry Sponsor
32 Previous Clinical Trials
11,009 Total Patients Enrolled
Bardia Nourbakhsh, MDPrincipal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
141 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
141 Patients Enrolled for Multiple Sclerosis