Trial Outcomes & Findings for A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia (NCT NCT03110315)

NCT ID: NCT03110315

Last Updated: 2025-02-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: Change from Baseline to 2 Weeks
• Results posted on: 2025-02-03

Participant Flow

36 subjects were enrolled

Subjects were randomized 1:1 to 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 or matching placebo. The subjects crossed over to opposite treatment for two weeks following a 1-week washout

Participant milestones

Measure	Suvorexant Followed by Placebo 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. Suvorexant: See detailed information in associated Arm Description.	Placebo Followed by Suvorexant Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.
Overall Study STARTED	18	18
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Suvorexant Followed by Placebo 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. Suvorexant: See detailed information in associated Arm Description.	Placebo Followed by Suvorexant Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Suvorexant Followed by Placebo n=18 Participants 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. After one week washout, Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Suvorexant: See detailed information in associated Arm Description. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Placebo Followed by Suvorexant n=18 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. After one week washout, 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. Suvorexant: See detailed information in associated Arm Description. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	50.333 years STANDARD_DEVIATION 13.412 • n=5 Participants	55.118 years STANDARD_DEVIATION 10.775 • n=7 Participants	52.657 years STANDARD_DEVIATION 12.616 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=35 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Suvorexant n=35 Participants 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. Suvorexant: See detailed information in associated Arm Description.
Change in Insomnia Severity Index (ISI) Score	-2 score on a scale Interval -5.0 to 0.0	-4 score on a scale Interval -8.0 to -2.0

SECONDARY outcome

Timeframe: Change from Baseline to 2 Weeks

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.

Outcome measures

Measure	Placebo n=35 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Suvorexant n=35 Participants 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. Suvorexant: See detailed information in associated Arm Description.
Change in Modified Fatigue Index Scale (MFIS) Score	-8.5 score on a scale Interval -15.0 to 1.5	-10.5 score on a scale Interval -16.5 to -3.5

SECONDARY outcome

Timeframe: Change from Baseline to 2 Weeks

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.

Outcome measures

Measure	Placebo n=35 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Suvorexant n=35 Participants 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. Suvorexant: See detailed information in associated Arm Description.
Patient Global Impression of Change	0 score on a scale Interval 0.0 to 1.0	0 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Change from Baseline to 2 Weeks

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.

Outcome measures

Measure	Placebo n=35 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Suvorexant n=35 Participants 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. Suvorexant: See detailed information in associated Arm Description.
Fatigue Visual Analog Scale	-5 score on a scale Interval -15.0 to 0.0	-5 score on a scale Interval -20.0 to 5.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 2 Weeks

A measure of minutes between being awake and falling asleep.

Outcome measures

Measure	Placebo n=35 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Suvorexant n=35 Participants 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. Suvorexant: See detailed information in associated Arm Description.
Sleep Latency	-2.8 Minutes Interval -17.45 to 10.38	-4.29 Minutes Interval -26.05 to 5.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 2 Weeks

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. 1 is Minimum, 4 is maximum. A higher score means a better outcome.

Outcome measures

Measure	Placebo n=35 Participants Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.	Suvorexant n=35 Participants 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. Suvorexant: See detailed information in associated Arm Description.
Subjective Quality of Sleep (sQUAL)	0 Score on a Scale Interval 0.0 to 1.0	0 Score on a Scale Interval 0.0 to 1.0

Adverse Events

Suvorexant

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Suvorexant n=35 participants at risk 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. Suvorexant: See detailed information in associated Arm Description.	Placebo n=35 participants at risk Placebo - one tablet taken by mouth once daily at bedtime and two tablets taken by mouth daily at bedtime if subject up-titrates. Placebo: Sugar pill manufactured to mimic suvorexant 10 mg tablet.
General disorders Headache	8.6% 3/35 • Number of events 3 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.	2.9% 1/35 • Number of events 1 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.
General disorders Sleep Disturbance	5.7% 2/35 • Number of events 2 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.	0.00% 0/35 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.
General disorders Dry Mouth	2.9% 1/35 • Number of events 1 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.	0.00% 0/35 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.
General disorders Dizziness	2.9% 1/35 • Number of events 1 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.	0.00% 0/35 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.
Psychiatric disorders Increased Depression	2.9% 1/35 • Number of events 1 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.	0.00% 0/35 • 5 weeks from Baseline to end of study. All adverse events were captured after the subject baseline date when they were randomized into either arm. For each reported adverse event, the subjects were followed until resolution of the adverse event or the end of the study.

Additional Information

Theodore Brown

EvergreenHealth Research

Phone: 4258995385

Email: trbrown@evergreenhealthcare.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place