NCT02684136

Suvorexant in Insomnia Co-morbid With Fibromyalgia

Terminated Phase 4 Results posted Last updated 16 June 2021

What this trial tests

Phase 4 trial testing suvorexant in Insomnia in 10 participants. Terminated before completion.

Timeline

1 February 2016

Primary endpoint
1 July 2018

1 July 2018

Quick facts

Lead sponsor	Henry Ford Health System
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	10
Start date	1 February 2016
Primary completion	1 July 2018
Estimated completion	1 July 2018
Sites	1 location across United States

Drugs / interventions tested

• suvorexant — full drug profile →
• placebo

Conditions studied

• Insomnia — all drugs for Insomnia →
• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Henry Ford Health System — full company profile →

Who can join

Adults 21 to 65, female only, with Insomnia or Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Polysomnographic Assessment of Sleep Primary · continuous sleep recording from 11pm to 7am on night 8

total sleep time on 8 hr standard sleep recording

Group	Value	95% CI
Suvorexant	429.3	± 29.4
Placebo	400.5	± 57.3

Daytime Pain Sensitivity Secondary · mean of tests at 1100 and 1500 hrs on both day 1 and day 8

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

Group	Value	95% CI
Suvorexant	15.8	± 5.4
Placebo	14.7	± 4.9

Adverse events — posted to ClinicalTrials.gov

Time frame: nightly over the 9 nights. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Suvorexant

Serious: 0/10 (0%)

Deaths: 0/10

Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Suvorexant	Placebo
headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02684136 adverse events section.

Sponsor's own description

This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo.
   Roehrs T, Withrow D, Koshorek G, Verkler J, et al · · 2020 · cited 20× · PMID 31992394 · DOI 10.5664/jcsm.8220