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

Phase 4

Terminated

• Conditions: Migraine Headache
• Interventions: Drug: ramelteon

• Registration Number: NCT00391755
• Lead Sponsor: Charlottesville Neuroscience

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-22
• Study First Submitted QC: 2006-10-23
• Study First Posted: 2006-10-24
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ramelteon	ramelteon 8 mg po qhs with sleep and migraine journal
2	ramelteon	Placebo po qhs with sleep and migraine journal

Primary Outcome Measures

Name	Time	Method
Statistically significant reduction in migraine headaches in the Rozerem treated group.	4 months

Secondary Outcome Measures

Name	Time	Method
Improvement in sleep satisfaction in the Rozerem treated group.	4 months

Trial Locations

Locations (1)

Patricia Shipley, MD; 🇺🇸 Charlottesville, Virginia, United States