NCT02684136

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 28, 2021

Completed
Last Updated

June 16, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

January 22, 2016

Results QC Date

August 22, 2019

Last Update Submit

May 26, 2021

Conditions

InsomniaFibromyalgia

Keywords

insomniafibromyalgiapolysomnographypain management

Outcome Measures

Primary Outcomes (1)

  • Polysomnographic Assessment of Sleep

    total sleep time on 8 hr standard sleep recording

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

Secondary Outcomes (1)

  • Daytime Pain Sensitivity

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

Study Arms (2)

suvorexant

EXPERIMENTAL

9 nights of 20 mg suvorexant

Drug: suvorexant

placebo

PLACEBO COMPARATOR

9 nights placebo

Drug: placebo

Interventions

suvorexantDRUG

suvorexant 20 mg taken before sleep

Also known as: belsomra
suvorexant
placeboDRUG

placebo taken before sleep

Also known as: matching placebo
placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meet Diagnostic and Statistical Manual 5th ed criteria for insomnia
  • meet American College of Rheumatology criteria for fibromyalgia
  • otherwise good psychiatric and stable physical health

You may not qualify if:

  • other primary sleep disorders
  • pain symptoms unrelated to fibromyalgia
  • current pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HFHS Sleep Disorders Ctr

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

    PMID: 20461783BACKGROUND

  • Roehrs T, Diederichs C, Gillis M, Burger AJ, Stout RA, Lumley MA, Roth T. Nocturnal sleep, daytime sleepiness and fatigue in fibromyalgia patients compared to rheumatoid arthritis patients and healthy controls: a preliminary study. Sleep Med. 2013 Jan;14(1):109-15. doi: 10.1016/j.sleep.2012.09.020. Epub 2012 Nov 11.

    PMID: 23149217BACKGROUND

  • Roehrs T, Withrow D, Koshorek G, Verkler J, Bazan L, Roth T. Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo. J Clin Sleep Med. 2020 Mar 15;16(3):415-421. doi: 10.5664/jcsm.8220. Epub 2020 Jan 14.

    PMID: 31992394DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersFibromyalgiaAgnosia

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Study closed after 18 moinths due to difficulty recruiting additional subjects beyond the 10 completed.

Results Point of Contact

Title
Timothy Roehrs PhD Study Investigator
Organization
HenryFordHS
troehrs1@hfhs.org
313-916-5177

Study Officials

  • Timothy Roehrs, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

  • Thomas Roth, PhD

    Henry Ford Health System

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Bioscientist

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 17, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 16, 2021

Results First Posted

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)