Phase 4
N=79
Treatment of Insomnia in Migraineurs
Insomnia · Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00812214 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Total Sleep Time — 5.4; 5.5; 6.3; 6.1 hours — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- eszopiclone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedVadis Research Corporation
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time |
5.4; 5.5; 6.3; 6.1 | 0.33 |
| SECONDARY Nighttime Awakenings |
1.5; 2.1 | — |
| SECONDARY Nighttime Awakenings |
1.5; 2.1 | — |
| SECONDARY Quality of Sleep |
5.1; 4.9; 6.7; 6.2; 6.1; 6.0 | 0.1 |
| SECONDARY Daytime Fatigue |
4.3; 4.8 | — |
| SECONDARY Headache Frequency |
2.9; 3.1; 2.5; 2.5 | 0.89 |
| SECONDARY Headache Duration |
4.0; 3.7; 3.9; 3.8 | 0.98 |
| SECONDARY Headache Intensity |
5.6; 5.3; 5.5; 5.6 | 0.82 |
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.
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00812214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.