Melatonin for Migraine Prevention (MMP)

Nordlandssykehuset HF

Status and phase

Completed

Phase 2

Conditions

Migraine

Treatments

Drug: melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT00849511

270472

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.