Multiple SclerosisPhase 2SOLARIMSNCT06170970
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
A Phase 2 study testing Solriamfetol in people with Multiple Sclerosis and Multiple Sclerosis Fatigue, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis Fatigue
- What is being tested?
- Solriamfetol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 2024 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)
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- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Mahsa Ghajarzadeh, MD, PhD, 410-614-1522, mghajar2@jhmi.edu
Lauren Vega, BSN, 410-614-1522, Ldimarc2@jhmi.edu
About this study
Official title: Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis Fatigue
- Being tested
- Solriamfetol, Placebo
- Keywords
- multiple sclerosis, fatigue, daytime sleepiness
- Medical subject headings
- Multiple Sclerosis, Fatigue, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolriamfetolDrug
Also called Sunosi
solriamfetol 75 mg daily for 3 days and will increase the dose to 150 mg daily starting on day 4 of the treatment period (total of four weeks)
PlaceboDrug
Four weeks of oral placebo
| Study group | Role | What they receive |
|---|---|---|
| solriamfetol then placebo first | Experimental | Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo Receives: Drug: Solriamfetol; Drug: Placebo |
| placebo then solriamfetol first | Experimental | Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol Receives: Drug: Solriamfetol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Scale (MFIS) Score
MFIS score measured during the last three days of each 4-week medication period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
Measured: Up to 4 weeks
Secondary outcomes (2)
Fatigue Severity Scale (FSS) Score
FSS score measured during the last three days of each 4-week medication period. The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue.
Measured: Up to 4 weeks
Epworth Sleepiness Scale (ESS) Score
ESS score measured during the last three days of each 4-week medication period. The total score of the ESS ranges from 0 to 24. Higher scores denote more severe daytime sleepiness.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jun 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Axsome Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Bardia Nourbakhsh, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170970
- Sponsor's protocol ID
- IRB00295382
- Acronym
- SOLARIMS
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators have set a timeline for data availability, commencing one year after the publication of the trial's main findings and extending for a period of five years. This timeframe ensures data relevance while providing ample opportunity for research exploration. Access to the data will be governed by a stringent but fair set of criteria. Interested researchers must submit a methodologically sound proposal, which will be evaluated by an independent review panel. This process ensures that the data are used to pursue scientifically valuable and ethically sound objectives. Researchers accessing the data must agree to terms that uphold privacy, ensure data security, and prohibit the further sharing of data with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
- ClinicalTrials.gov ID
- NCT06170970
- Acronym / sponsor ID
- SOLARIMS / IRB00295382
- Conditions
- Multiple Sclerosis, Multiple Sclerosis Fatigue
- Keywords
- multiple sclerosis, fatigue, daytime sleepiness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Axsome Therapeutics, Inc.
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solriamfetol then placebo first | Experimental | Drug: Solriamfetol, Drug: PlaceboFour weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo |
| placebo then solriamfetol first | Experimental | Drug: Solriamfetol, Drug: PlaceboFour weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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 2024 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolriamfetolAlso: Sunosisolriamfetol 75 mg daily for 3 days and will increase the dose to 150 mg daily starting on day 4 of the treatment period (total of four weeks) | Drug | placebo then solriamfetol first, solriamfetol then placebo first |
| PlaceboFour weeks of oral placebo | Drug | placebo then solriamfetol first, solriamfetol then placebo first |
Primary outcome
Modified Fatigue Impact Scale (MFIS) Score
Time frame: Up to 4 weeks
MFIS score measured during the last three days of each 4-week medication period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
2 secondary outcomes
Fatigue Severity Scale (FSS) Score
Time frame: Up to 4 weeks
Epworth Sleepiness Scale (ESS) Score
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. The investigators have set a timeline for data availability, commencing one year after the publication of the trial's main findings and extending for a period of five years. This timeframe ensures data relevance while providing ample opportunity for research exploration. Access to the data will be governed by a stringent but fair set of criteria. Interested researchers must submit a methodologically sound proposal, which will be evaluated by an independent review panel. This process ensures that the data are used to pursue scientifically valuable and ethically sound objectives. Researchers accessing the data must agree to terms that uphold privacy, ensure data security, and prohibit the further sharing of data with third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bardia Nourbakhsh, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solriamfetol in people with Multiple Sclerosis and Multiple Sclerosis Fatigue, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Vega, BSN (410-614-1522, Ldimarc2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Impact Scale (MFIS) Score (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.