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

This study has been terminated.
(Failure to recruit necessary number of patients.)
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Patricia Shipley, MD, Charlottesville Neuroscience Identifier:
First received: October 22, 2006
Last updated: February 8, 2012
Last verified: February 2012
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.

Condition Intervention Phase
Migraine Headache
Drug: ramelteon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

Resource links provided by NLM:

Further study details as provided by Charlottesville Neuroscience:

Primary Outcome Measures:
  • Statistically significant reduction in migraine headaches in the Rozerem treated group. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Improvement in sleep satisfaction in the Rozerem treated group. [ Time Frame: 4 months ]

Enrollment: 4
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ramelteon 8 mg po qhs with sleep and migraine journal
Drug: ramelteon
  1. ramelteon 8mg po qhs with sleep and headache diary
  2. placebo 1 po qhs with sleep and headache diary
Other Name: Rozerem
Placebo Comparator: 2
Placebo po qhs with sleep and migraine journal
Drug: ramelteon
  1. ramelteon 8mg po qhs with sleep and headache diary
  2. placebo 1 po qhs with sleep and headache diary
Other Name: Rozerem

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00391755

United States, Virginia
Patricia Shipley, MD
Charlottesville, Virginia, United States, 22902
Sponsors and Collaborators
Charlottesville Neuroscience
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Patricia J Shipley, MD Charlottesville Neuroscience
  More Information

Responsible Party: Patricia Shipley, MD, Principal Investigator, Charlottesville Neuroscience Identifier: NCT00391755     History of Changes
Other Study ID Numbers: 06-013R
Study First Received: October 22, 2006
Last Updated: February 8, 2012

Keywords provided by Charlottesville Neuroscience:
Migraine Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 24, 2017