Status:
COMPLETED
Treatment of Insomnia in Migraineurs
Lead Sponsor:
MedVadis Research Corporation
Conditions:
Insomnia
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 headac...
Detailed Description
The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolon...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00812214
Start Date
April 1 2007
End Date
September 1 2008
Last Update
June 15 2023
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