Trial Outcomes & Findings for Suvorexant in Insomnia Co-morbid With Fibromyalgia (NCT NCT02684136)

NCT ID: NCT02684136

Last Updated: 2021-06-16

Results Overview

total sleep time on 8 hr standard sleep recording

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: continuous sleep recording from 11pm to 7am on night 8
• Results posted on: 2021-06-16

Participant Flow

Participant milestones

Measure	Suvorexant First, Then Placebo 9 nights of 20 mg suvorexant first, then 9 nights of placebo suvorexant: suvorexant 20 mg taken before sleep; placebo taken before sleep	Placebo First, Then Suvorexant 9 nights placebo first, washout, then 9 nights of 20 mg suvorexant: suvorexant 20 mg taken before sleep; placebo taken before sleep
First Intervention (9 Nights) STARTED	5	5
First Intervention (9 Nights) COMPLETED	5	5
First Intervention (9 Nights) NOT COMPLETED	0	0
Washout (7 Days) STARTED	5	5
Washout (7 Days) COMPLETED	5	5
Washout (7 Days) NOT COMPLETED	0	0
Second Intervention (9 Nights) STARTED	5	5
Second Intervention (9 Nights) COMPLETED	5	5
Second Intervention (9 Nights) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suvorexant in Insomnia Co-morbid With Fibromyalgia

Baseline characteristics by cohort

Measure	All Study Participants n=10 Participants this is a crossover study with 20 mg suvorexant and placebo each administered for 9 nights
Age, Continuous	50.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Total Sleep Time	346.9 min of total sleep time on a 8-hr PSG STANDARD_DEVIATION 52.32 • n=5 Participants

PRIMARY outcome

Timeframe: continuous sleep recording from 11pm to 7am on night 8

Population: this is crossover study so all 10 Ss received both placebo and suvorexant

total sleep time on 8 hr standard sleep recording

Outcome measures

Measure	Suvorexant n=10 Participants 9 nights of 20 mg suvorexant suvorexant: suvorexant 20 mg taken before sleep	Placebo n=10 Participants 9 nights placebo placebo: placebo taken before sleep
Polysomnographic Assessment of Sleep	429.3 min Standard Deviation 29.4	400.5 min Standard Deviation 57.3

SECONDARY outcome

Timeframe: mean of tests at 1100 and 1500 hrs on both day 1 and day 8

Population: this is a crossover study so all 10 Ss received placebo and suvorexant

finger withdrawal response to a radiant heat stimulus when pain is first experienced

Outcome measures

Measure	Suvorexant n=10 Participants 9 nights of 20 mg suvorexant suvorexant: suvorexant 20 mg taken before sleep	Placebo n=10 Participants 9 nights placebo placebo: placebo taken before sleep
Daytime Pain Sensitivity	15.8 sec Standard Deviation 5.4	14.7 sec Standard Deviation 4.9

Adverse Events

Suvorexant

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Suvorexant n=10 participants at risk 9 nights of 20 mg suvorexant suvorexant: suvorexant 20 mg taken before sleep	Placebo n=10 participants at risk 9 nights placebo placebo: placebo taken before sleep
Nervous system disorders headache	80.0% 8/10 • Number of events 17 • nightly over the 9 nights this is a crossover study and all 10 Ss were at risk in the placebo and suvorexant arms	30.0% 3/10 • Number of events 3 • nightly over the 9 nights this is a crossover study and all 10 Ss were at risk in the placebo and suvorexant arms

Additional Information

Timothy Roehrs PhD Study Investigator

HenryFordHS

Phone: 313-916-5177

Email: troehrs1@hfhs.org

Results disclosure agreements

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