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

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00391755
• Other study ID #: 06-013R
• Status: Terminated
• Phase: Phase 4
• First received: October 22, 2006
• Last updated: February 8, 2012
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: February 2012
• Source: Charlottesville Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

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

Locations

Country	Name	City	State
United States	Patricia Shipley, MD	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Charlottesville Neuroscience	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

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

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

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. — View Citation

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistically significant reduction in migraine headaches in the Rozerem treated group.		4 months	No
Secondary	Improvement in sleep satisfaction in the Rozerem treated group.		4 months	No