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

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ClinicalTrials.gov Identifier: NCT00391755
Recruitment Status : Terminated (Failure to recruit necessary number of patients.)
First Posted : October 24, 2006
Last Update Posted : February 10, 2012
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Patricia Shipley, MD, Charlottesville Neuroscience

October 22, 2006
October 24, 2006
February 10, 2012
October 2006
October 2009   (Final data collection date for primary outcome measure)
Statistically significant reduction in migraine headaches in the Rozerem treated group. [ Time Frame: 4 months ]
Statistically significant reduction in migraine headaches in the Rozerem treated group.
Complete list of historical versions of study NCT00391755 on ClinicalTrials.gov Archive Site
Improvement in sleep satisfaction in the Rozerem treated group. [ Time Frame: 4 months ]
Improvement in sleep satisfaction in the Rozerem treated group.
Not Provided
Not Provided
 
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Migraine Headache
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
  • Active Comparator: 1
    ramelteon 8 mg po qhs with sleep and migraine journal
    Intervention: Drug: ramelteon
  • Placebo Comparator: 2
    Placebo po qhs with sleep and migraine journal
    Intervention: Drug: ramelteon

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
24
October 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00391755
06-013R
Yes
Not Provided
Not Provided
Patricia Shipley, MD, Charlottesville Neuroscience
Charlottesville Neuroscience
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Patricia J Shipley, MD Charlottesville Neuroscience
Charlottesville Neuroscience
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP