Clinical trial NCT00391755: A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Official title: A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Migraine Headache
Keywords: Migraine Headache
Lead sponsor: Charlottesville Neuroscience
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2006-10-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Statistically significant reduction in migraine headaches in the Rozerem treated group.
timeFrame: 4 months
Secondary outcomes:
measure: Improvement in sleep satisfaction in the Rozerem treated group.
timeFrame: 4 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Patricia Shipley, MD
state: Virginia
Study officials:
affiliation: Charlottesville Neuroscience
name: Patricia J Shipley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahota PK, Dexter JD. Sleep and headache syndromes: a clinical review. Headache. 1990 Jan;30(2):80-4. doi: 10.1111/j.1526-4610.1990.hed3002080.x.
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. doi: 10.1111/j.1526-4610.2005.05159.x.
citation: Boardman HF, Thomas E, Millson DS, Croft PR. Psychological, sleep, lifestyle, and comorbid associations with headache. Headache. 2005 Jun;45(6):657-69. doi: 10.1111/j.1526-4610.2005.05133.x.
citation: Bruni O, Galli F, Guidetti V. Sleep hygiene and migraine in children and adolescents. Cephalalgia. 1999 Dec;19 Suppl 25:57-9. doi: 10.1177/0333102499019s2516.
citation: Bahra A, Matharu MS, Buchel C, Frackowiak RS, Goadsby PJ. Brainstem activation specific to migraine headache. Lancet. 2001 Mar 31;357(9261):1016-7. doi: 10.1016/s0140-6736(00)04250-1.
citation: Peres MF. Melatonin, the pineal gland and their implications for headache disorders. Cephalalgia. 2005 Jun;25(6):403-11. doi: 10.1111/j.1468-2982.2005.00889.x.
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. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.