Melatonin for Migraine Prevention

Study Overview
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Brief Summary
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The circadian system with its centre in the hypothalamus is involved in migraine pathophysiology. Whether it plays a pivotal role is not clarified. The investigators postulate that a destabilized circadian system may increase migraine attack susceptibility, and that stabilization by supplying melatonin a migraine preventive effect will be achieved. A previous open label study has shown effects that certainly warrant a placebo controlled study.

Official Title
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Melatonin for Migraine Prevention (The MMP-study): A Randomized, Double-blind, Cross-over, Placebo-controlled Study of Melatonin in Prophylactic Treatment of Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 65 years, both male and females. Migraine present for at least 1 year and fulfilling diagnostic criteria that conform to those of the International Headache Society (HIS) [2] but otherwise healthy. Attacks of migraine should occur 4-6 times per month, there should be no regular use of other drugs, and the patient has to be able to differentiate between migraine headache and non-migrainous headache. Preventive drugs for migraine should not have been used the last three months. Conventional acute attack treatment is accepted, but not sporadic use of other drugs like hypnotics and anxiolytics. Residence of North-Norway. Exclusion Criteria: Medication overuse headache, chronic migraine. Pregnant and breast feeding women. Patient with either serious co-morbidity or conditions requiring medical treatment or caution. Psychiatric disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo first<br>Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks | Drug: melatonin<br>* Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks<br>* Other names: Circadin;|
| Active Comparator: Melatonin first<br>Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks | Drug: melatonin<br>* Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks<br>* Other names: Circadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine attack frequency |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index score |  | 8 weeks | 
| Night time sleep quality |  | 8 weeks | 
| Point prevalence of insomnia |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine prevention, Crossover, Melatonin