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

Sponsor:	Charlottesville Neuroscience
Collaborator:	Takeda Pharmaceuticals North America, Inc.
Information provided by:	Charlottesville Neuroscience
ClinicalTrials.gov Identifier:	NCT00391755

Purpose

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Ramelteon

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in sleep satisfaction in the Rozerem treated group. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	October 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ramelteon 8 mg po qhs with sleep and migraine journal	Drug: ramelteon ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary
2: Placebo Comparator Placebo po qhs with sleep and migraine journal	Drug: ramelteon ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391755

Contacts

Contact: Patricia J Shipley, MD	434-293-0866	Patricia.Shipley@MJH.org
Contact: Pari Nikpey, MD	434-293-5181	Nikpey@gmail.com

Locations

United States, Virginia
Patricia Shipley, MD	Recruiting
Charlottesville, Virginia, United States, 22902

Sponsors and Collaborators

Charlottesville Neuroscience

Takeda Pharmaceuticals North America, Inc.

Investigators

Principal Investigator:

Patricia J Shipley, MD

Charlottesville Neuroscience

More Information

Publications:

Sahota PK, Dexter JD. Sleep and headache syndromes: a clinical review. Headache. 1990 Jan;30(2):80-4. Review.

Kelman L, Rains JC. Headache and sleep: examination of sleep patterns and complaints in a large clinical sample of migraineurs. Headache. 2005 Jul-Aug;45(7):904-10.

Boardman HF, Thomas E, Millson DS, Croft PR. Psychological, sleep, lifestyle, and comorbid associations with headache. Headache. 2005 Jun;45(6):657-69.

Bruni O, Galli F, Guidetti V. Sleep hygiene and migraine in children and adolescents. Cephalalgia. 1999 Dec;19 Suppl 25:57-9.

Bahra A, Matharu MS, Buchel C, Frackowiak RS, Goadsby PJ. Brainstem activation specific to migraine headache. Lancet. 2001 Mar 31;357(9261):1016-7.

Peres MF. Melatonin, the pineal gland and their implications for headache disorders. Cephalalgia. 2005 Jun;25(6):403-11. Review.

Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. No abstract available.

Responsible Party:	Charlottesville Neuroscience ( Patricia Shipley MD, Medical Director )
Study ID Numbers:	06-013R
Study First Received:	October 22, 2006
Last Updated:	February 1, 2009
ClinicalTrials.gov Identifier:	NCT00391755 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Charlottesville Neuroscience:

Migraine Headache

Additional relevant MeSH terms:

Signs and Symptoms
Migraine Disorders
Nervous System Diseases
Headache
Central Nervous System Diseases

Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on February 08, 2010