Melatonin for Migraine Prevention

Nordlandssykehuset HF48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Migraine

Interventions

melatoninDRUG

Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Departement of Neurology, NLSH HF

Bodø, Norway

Departement of Neurology

Tromsø, Norway

Outcomes

Primary Outcomes

Migraine attack frequency

Time frame: 8 weeks

Secondary Outcomes

Pittsburgh Sleep Quality Index score

Time frame: 8 weeks

Night time sleep quality

Time frame: 8 weeks

Point prevalence of insomnia

Time frame: 8 weeks

Data from ClinicalTrials.gov

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