- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03110315
A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia (DREAM)
March 21, 2022 updated by: Theodore R. Brown, MD MPH
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Kirkland, Washington, United States, 98034
- EvergreenHealth Multiple Sclerosis Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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-specific screening procedures have been performed.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Suvorexant
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.
|
See detailed information in associated Arm Description.
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates.
|
Sugar pill manufactured to mimic suvorexant 10 mg tablet.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insomnia Severity Index (ISI) score
Time Frame: Week 1, Week 3, Week 7
|
7-question survey assessing symptoms of insomnia over the past week.
Maximum score is 28, with higher scores indicating greater severity.
|
Week 1, Week 3, Week 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Quality of Sleep (sQUAL)
Time Frame: Week 1, Week 3, Week 7
|
This is a single question, "How would you describe the quality of your sleep last night?"
There are 4 choices to answer: 1= poor, 2 = fair, 3= good, 4= excellent
|
Week 1, Week 3, Week 7
|
Subjective refreshed feeling on waking (sFRESH)
Time Frame: Week 1, Week 3, Week 7
|
This is a single question, "How refreshed do you feel this morning?"
There are 5 choices to answer: 1 = not at all refreshed, 2 = a little refreshed, 3 = moderately refreshed, 4 = quite a bit refreshed, 5 = extremely refreshed
|
Week 1, Week 3, Week 7
|
Change in Modified Fatigue Index Scale (MFIS) score
Time Frame: Week 1, Week 3, Week 7
|
This scale has 21 items with physical, cognitive and psychosocial subscales.
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.
|
Week 1, Week 3, Week 7
|
Subjective Global Impression of Change
Time Frame: Week 1, Week 3, Week 7
|
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".
|
Week 1, Week 3, Week 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Theodore R Brown, MD, MPH, EvergreenHealth Multiple Sclerosis Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 28, 2017
Primary Completion (ACTUAL)
March 21, 2022
Study Completion (ACTUAL)
March 21, 2022
Study Registration Dates
First Submitted
March 28, 2017
First Submitted That Met QC Criteria
April 6, 2017
First Posted (ACTUAL)
April 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2022
Last Update Submitted That Met QC Criteria
March 21, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Multiple Sclerosis
- Sclerosis
- Fatigue
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- Sleep Aids, Pharmaceutical
- Orexin Receptor Antagonists
- Suvorexant
Other Study ID Numbers
- TRB 2017.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share individual participant data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Suvorexant
-
The University of Texas Health Science Center,...Recruiting
-
The University of Texas Health Science Center,...Peter F. McManus Charitable TrustCompletedAnxiety | Cocaine Use DisorderUnited States
-
Mclean HospitalRecruiting
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSleep Disturbance | Opioid Dependence | Opioid WithdrawalUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Henry Ford Health SystemCompleted
-
Howard UniversityNational Institute of Mental Health (NIMH); Georgetown-Howard Universities...CompletedPosttraumatic Stress DisorderUnited States
-
Massachusetts General HospitalWithdrawnInsomnia | Bipolar Disorder
-
Jichi Medical UniversityMerck Sharp & Dohme LLC; Satt Co.,LtdCompletedHypertension | InsomniaJapan