Trial | NCT00391755  Report issue

Official Title

A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    ramelteon ...

  • Study Participants

    4
To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.
In a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. Those who had shorter average sleep times reported more severe headaches. Poor sleep has been associated with increased frequency and severity of migraines. The improvement of migraine frequency with improved sleep hygiene has been documented.

PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches. Polysomnography has shown specific headache types to occur in specific sleep stages.

Melatonin has been effective primarily in headache due to delayed sleep phase syndrome. Recent studies support the efficacy of melatonin in treating migraine. The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication. If effective, the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep.

Hypothesis: Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.
Study Started
Oct 31
2006
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Last Update
Feb 10
2012
Estimate

Drug ramelteon

ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary

  • Other names: Rozerem

1 Active Comparator

ramelteon 8 mg po qhs with sleep and migraine journal

2 Placebo Comparator

Placebo po qhs with sleep and migraine journal

Criteria 

Inclusion Criteria:

Age 18-65
3-8 Migraine headaches/month
Able to understand and comply with the study

Exclusion Criteria:

Currently on migraine prophylaxis
Currently on sleep medication > 4days/month
Currently on Fluvoxamine
Untreated psychiatric or sleep disorders
MRI abnormalities other than those attributable to migraine headaches
Abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep
Known disorders of prolactin
Bipolar disorder
Hepatic disease
Pregnancy
No Results Posted