CompletedPhase 4

A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

United States36 participantsStarted 2017-03-28

Plain-language summary

This study assesses the safety, tolerability, and efficacy of suvorexant in multiple sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater improvement in sleep, as measured by symptom rating scales, compared to placebo.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of multiple sclerosis made at least 3 months prior based on McDonald criteria; * Age 18-75 inclusive; * Expanded Disability Status Scale (EDSS) 0- 7.5; * Clinical stability defined as no multiple sclerosis exacerbation or change in disease modifying therapy for 60 days prior to screening; * Screening Fatigue Severity Scale score of ≥4.0; * Has Insomnia Disorder defined by diagnostic criteria published in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); namely, subject report of all of the following: * One of the following: difficulty initiating sleep; difficulty maintaining sleep; or early morning waking; * Sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning; * Sleep difficulty has occurred on 3 or more nights per week; * Sleep difficulty has been present for at least the past 3 months; * Sleep difficulty occurs despite adequate opportunity for sleep; * Insomnia is not explained by another sleep disorder; * Insomnia is not attributable to physiological effects of a consumed substance; * May use other medications that could influence sleep, other than those specifically prohibited, as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study; * Signed and dated Institutional Review Board-approved informed consent form before any protocol-speci…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insomnia Severity Index (ISI) Score

Timeframe: Change from Baseline to 2 Weeks

Trial details

NCT IDNCT03110315

SponsorTheodore R. Brown, MD MPH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-21

Results submitted2024-11-15

View on ClinicalTrials.gov More Multiple Sclerosis trials