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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 February 2025
• Main ID: NCT03110315
• Date of registration: 28/03/2017
• Prospective Registration: Yes
• Primary sponsor: Theodore R. Brown, MD MPH
• Public title: A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia DREAM
• Scientific 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
• Date of first enrolment: March 28, 2017
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03110315
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Theodore R Brown, MD, MPH
• Affiliation: EvergreenHealth Multiple Sclerosis Center

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Insomnia

Fatigue

Multiple Sclerosis

Intervention(s)

Drug: Suvorexant

Drug: Placebo

Primary Outcome(s)

Change in Insomnia Severity Index (ISI) Score [Time Frame: Change from Baseline to 2 Weeks]

Secondary Outcome(s)

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]

Change in Modified Fatigue Index Scale (MFIS) Score [Time Frame: Change from Baseline to 2 Weeks]

Secondary ID(s)

TRB 2017.2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme LLC

Results

• Results available: Yes
• Date Posted: 03/02/2025
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03110315