Multiple SclerosisPhase 4DREAMNCT03110315
A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
A Phase 4 study testing Suvorexant in people with Multiple Sclerosis and Fatigue, run by Theodore R. Brown, MD MPH at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Insomnia
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 21 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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-specific screening procedures have been performed.
Who cannot join
- Use of potential multiple sclerosis-associated fatigue drugs within 3 days of screening until study completion, including modafinil, armodafinil, amantadine, methylphenidate, products with amphetamine or dextroamphetamine;
- Use of any of any prohibited medication (including Digoxin, benzodiazepines, barbiturates, opiates, Zolpidem, Zaleplon, Eszopiclone, moderate or strong CYP3A inhibitors, or strong inducers of CYP3A) from 3 days prior to screening to termination visit;
- Female who is breast-feeding, pregnant, or has the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures);
- History of narcolepsy;
- Has a diagnosis of severe chronic obstructive pulmonary disease (COPD), defined by forced expiratory volume 1 (FEV1) < 50% of predicted on most recent available pulmonary function test (PFT). Pulmonary function test is not required if the subject has never been diagnosed with chronic obstructive pulmonary disease;
- Has a history of severe obstructive sleep apnea (OSA), with severe obstructive sleep apnea defined as having an apnea-hypopnea index (AHI) > 30 on prior polysomnograph (PSG). Polysomnograph is not required if there is no history of obstructive sleep apnea;
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- Is concurrently using other central nervous system (CNS) depressants, including alcohol, except that one alcoholic drink per day will be allowed for those with normal hepatic function provided the drink is consumed at least 2 hours prior to or 8 hours after taking the study drug. Medical marijuana is allowed if consumed at the patient's usual dose at least 2 hours prior to or 8 hours after taking the study drug. Recreational marijuana is not allowed from screening until end of study;
- Has evidence at screening of severe hepatic impairment as defined by a Child-Pugh score > 10;
- Cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent;
- Suicidality or severe depression as measured by screening Beck Depression Inventory II (BDI) score > 28 or score of >1 on Beck Depression Inventory II Question 9 (suicidality screen) at any time during the study;
- Any other serious and/or unstable medical condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
EvergreenHealth Multiple Sclerosis Center
Kirkland, Washington, 98034
About this study
Official title: A Double-blind, Crossover, Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
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.
Read the detailed description
The target enrollment number is 30 people with multiple sclerosis who meet inclusion criteria. After informed consent is given, potential subjects will be screened to ensure they meet eligibility criteria. Subjects who meet eligibility criteria will complete baseline assessments and will then be randomized to receive 2 weeks of treatment (Treatment Period 1) with either suvorexant or matching placebo (1:1). The initial dose of suvorexant will be 10 mg at bedtime, with optional titration to 20 mg after 5-7 days. Study drug will be dispensed by an independent research pharmacist, keeping both study staff and the subject blinded. All subjects, whether in placebo or active arm, will receive a wearable sleep monitor to be worn for 7 days at baseline, and during both treatment periods. All subjects will keep 7-day sleep diaries at baseline and during each study period. At the end of Treatment Period 1 (2 weeks), subjects will undergo efficacy assessments with repeated clinical scales. Subjects will then go through a 1-week open-label off-drug washout period. Subjects will then be crossed over into the alternate treatment group, which will once again be double-blinded; those on active treatment (suvorexant) in Treatment Period 1 will be switched to placebo, and those on placebo in Treatment Period 1 will be switched to active treatment. Treatment Period 2 will also be 2 weeks long, and at the end of this, subjects will undergo final assessment with clinical scales.
- Conditions
- Multiple Sclerosis, Fatigue, Insomnia
- Being tested
- Suvorexant, Placebo
- Keywords
- Multiple Sclerosis, Fatigue, Insomnia, Suvorexant, Belsomra, Sleep disorder, Sleep
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Also called Belsomra
See detailed information in associated Arm Description.
PlaceboDrug
Also called Sugar pill
Sugar pill manufactured to mimic suvorexant 10 mg tablet.
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant | Experimental | Suvorexant - 10 mg (one tablet) taken by mouth once daily at bedtime with option to up-titrate to 20 mg (two tablets) taken by mouth once daily at bedtime. Receives: Drug: Suvorexant |
| Placebo | Placebo comparator | Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) Score
7-question survey assessing symptoms of insomnia over the past week. Maximum score is 28, minimum is 0, with higher scores indicating greater severity.
Guidelines for Scoring/Interpretation:
Add scores for all seven items = _____ Total score ranges from 0-28 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate
Measured: Change from Baseline to 2 Weeks
Secondary outcomes (3)
Change in Modified Fatigue Index Scale (MFIS) Score
This scale has 21 items with physical, cognitive and psychosocial questions regarding their fatigue levels. Subjects will complete the Modified Fatigue Index Scale (MFIS) as the first test conducted on the day of visit. Their ratings on the 21-item questionnaire will be based on their fatigue experience over the previous 1 week. Each question is on a scale from 0 to 4. Higher scores represent worse fatigue. Minimum score is 0 and maximum score is 84.
Measured: Change from Baseline to 2 Weeks
Patient Global Impression of Change
This is a single question: "How would you rate change in your level of physical and mental function, during the study?" Responses range from "Extremely improved", "Much improved", "Slightly improved", "No change", "Slightly worse", "Much worse", and "Extremely worse". Higher score indicates improvement. Scale is 0-5 given responses. 0 is minimum, 5 is maximum.
Measured: Change from Baseline to 2 Weeks
Fatigue Visual Analog Scale
0-100 scale rating fatigue with 0 being not fatigued at all, 100 being fatigue as bad as can be. Patients are instructed to place an "X" on the scale based on their overall level of fatigue. On the low-end of the scale are feelings of being awake and alert, having high-energy and vigor. On the high end of the scale are feelings of tiredness, drowsiness, sluggishness, low-energy, lassitude.
Measured: Change from Baseline to 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start28 Mar 2017
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized cross-over trial of suvorexant and placebo for people with multiple sclerosis (MS), insomnia and fatigue
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodore R. Brown, MD MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Theodore R. Brown, MD MPH, EvergreenHealth
- Investigators
- Theodore R Brown, MD, MPH, Principal investigator, EvergreenHealth Multiple Sclerosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110315
- Sponsor's protocol ID
- TRB 2017.2
- Acronym
- DREAM
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2017
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Crossover, Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
- ClinicalTrials.gov ID
- NCT03110315
- Acronym / sponsor ID
- DREAM / TRB 2017.2
- Conditions
- Multiple Sclerosis, Fatigue, Insomnia
- Keywords
- Multiple Sclerosis, Fatigue, Insomnia, Suvorexant, Belsomra, Sleep disorder, Sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Theodore R. Brown, MD MPHUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The target enrollment number is 30 people with multiple sclerosis who meet inclusion criteria. After informed consent is given, potential subjects will be screened to ensure they meet eligibility criteria. Subjects who meet eligibility criteria will complete baseline assessments and will then be randomized to receive 2 weeks of treatment (Treatment Period 1) with either suvorexant or matching placebo (1:1). The initial dose of suvorexant will be 10 mg at bedtime, with optional titration to 20 mg after 5-7 days. Study drug will be dispensed by an independent research pharmacist, keeping both study staff and the subject blinded. All subjects, whether in placebo or active arm, will receive a wearable sleep monitor to be worn for 7 days at baseline, and during both treatment periods. All subjects will keep 7-day sleep diaries at baseline and during each study period. At the end of Treatment Period 1 (2 weeks), subjects will undergo efficacy assessments with repeated clinical scales. Subjects will then go through a 1-week open-label off-drug washout period. Subjects will then be crossed over into the alternate treatment group, which will once again be double-blinded; those on active treatment (suvorexant) in Treatment Period 1 will be switched to placebo, and those on placebo in Treatment Period 1 will be switched to active treatment. Treatment Period 2 will also be 2 weeks long, and at the end of this, subjects will undergo final assessment with clinical scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized cross-over trial of suvorexant and placebo for people with multiple sclerosis (MS), insomnia and fatigue
| Arm | Type | Receives |
|---|---|---|
| Suvorexant | Experimental | Drug: SuvorexantSuvorexant - 10 mg (one tablet) taken by mouth once daily at bedtime with option to up-titrate to 20 mg (two tablets) taken by mouth once daily at bedtime. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (11 listed)
- Use of potential multiple sclerosis-associated fatigue drugs within 3 days of screening until study completion, including modafinil, armodafinil, amantadine, methylphenidate, products with amphetamine or dextroamphetamine;
- Use of any of any prohibited medication (including Digoxin, benzodiazepines, barbiturates, opiates, Zolpidem, Zaleplon, Eszopiclone, moderate or strong CYP3A inhibitors, or strong inducers of CYP3A) from 3 days prior to screening to termination visit;
- Female who is breast-feeding, pregnant, or has the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures);
- History of narcolepsy;
- Has a diagnosis of severe chronic obstructive pulmonary disease (COPD), defined by forced expiratory volume 1 (FEV1) < 50% of predicted on most recent available pulmonary function test (PFT). Pulmonary function test is not required if the subject has never been diagnosed with chronic obstructive pulmonary disease;
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 |
|---|---|---|
| SuvorexantAlso: BelsomraSee detailed information in associated Arm Description. | Drug | Suvorexant |
| PlaceboAlso: Sugar pillSugar pill manufactured to mimic suvorexant 10 mg tablet. | Drug | Placebo |
Primary outcome
Change in Insomnia Severity Index (ISI) Score
Time frame: Change from Baseline to 2 Weeks
7-question survey assessing symptoms of insomnia over the past week. Maximum score is 28, minimum is 0, with higher scores indicating greater severity. Guidelines for Scoring/Interpretation: Add scores for all seven items = _____ Total score ranges from 0-28 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate
3 secondary outcomes
Change in Modified Fatigue Index Scale (MFIS) Score
Time frame: Change from Baseline to 2 Weeks
Patient Global Impression of Change
Time frame: Change from Baseline to 2 Weeks
Fatigue Visual Analog Scale
Time frame: Change from Baseline to 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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. This study is not recruiting at the moment.
Theodore R Brown, MD, MPH principal investigator
EvergreenHealth Multiple Sclerosis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suvorexant in people with Multiple Sclerosis and Fatigue, run by Theodore R. Brown, MD MPH 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 15 inclusion and 11 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: finished, as of the sponsor's last update on 3 Feb 2025. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) Score (time frame: Change from Baseline to 2 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 3 Feb 2025.