Treatment of Insomnia in Migraineurs

NCT00812214 | Completed Phase 4 Results

• 1 other identifier: ESRC024
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

Conditions

Insomnia; Migraine

Keywords

insomnia; migraine; eszopiclone; insomnia in migraineurs

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time

  Participants were asked to record an estimated total time asleep on a daily basis. Nightly estimates were averaged over a 2 week period for baseline and 6 week period so that the total sleep time represents the average total time asleep each night.

  Baseline, 6 weeks

Secondary Outcomes (7)

• Nighttime Awakenings

  Baseline, 6 weeks

• Nighttime Awakenings

  Measured every two weeks (1&2, 3&4, 5&6)

• Quality of Sleep

  Baseline, 6 weeks

• Daytime Fatigue

  Measured every two weeks (1&2, 3&4, 5&6)

• Headache Frequency

  Baseline, 6 weeks

Study Arms (2)

Eszopiclone (Lunesta) 3mg

EXPERIMENTAL

Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.

Drug: eszopiclone

Placebo

PLACEBO COMPARATOR

Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.

Drug: placebo

Interventions

eszopiclone DRUG

3 mg tablet every night at bedtime

Also known as: Lunesta

Eszopiclone (Lunesta) 3mg

placebo DRUG

1 tablet every night at bedtime

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 18 to 64 years of age (inclusive) with International Headache Society (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IV primary insomnia (sleep onset/sleep maintenance).
• Migraine frequency is 4-12 times per month, with a maximum of 20 days with headache per month, for 1 month or longer prior to screening.
• A usual, estimated total sleep time of 6½ hours per night or less, for 1 month or longer prior to screening, due to problems falling asleep, waking up during the night, or waking up early.

You may not qualify if:

• Abortive migraine treatment with schedule II-III opioids.
• Use of caffeine-containing medications, prescription and non-prescription, not exceeding 10 days per month.
• Preventive migraine treatment with tricyclics or anticonvulsants.
• Treatment of insomnia with non-prescription medications, such as diphenhydramine, melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates, benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.

Sponsors & Collaborators

• MedVadis Research Corporation: lead

Related Publications (1)

• Spierings EL, McAllister PJ, Bilchik TR. Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta(R)) and its effect on total sleep time, headache frequency, and daytime functioning: A randomized, double-blind, placebo-controlled, parallel-group, pilot study. Cranio. 2015 Apr;33(2):115-21. doi: 10.1179/0886963414Z.00000000084. Epub 2014 Oct 16.

  PMID: 25323219 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Migraine Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Egilius L.H. Spierings, M.D., Ph.D.
• Organization: MedVadis Research Corporation

Spierings@MedVadis.com

617-744-1310

Study Officials

• Egilius LH Spierings, M.D., Ph.D.

  MedVadis Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: April 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05