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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
| Axsome Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solriamfetol then placebo first | Experimental | Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 weeks |
| Epworth Sleepiness Scale (ESS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Vega, BSN | Contact | 410-614-1522 | Ldimarc2@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bardia Nourbakhsh, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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.
one year after the publication of the main trial results to 5 years after the publication.
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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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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|
| Placebo | Drug | Four weeks of oral placebo |
|
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. |
| Up to 4 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |