Melatonin for Migraine Prevention

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00849511

Acronym

MMP

Enrollment

Registered

2009-02-24

Start date

2009-02-28

Completion date

2009-10-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine prevention, Crossover, Melatonin

Brief summary

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.

Interventions

DRUGmelatonin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Migraine attack frequency	8 weeks

Secondary

Measure	Time frame
Pittsburgh Sleep Quality Index score	8 weeks
Night time sleep quality	8 weeks
Point prevalence of insomnia	8 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026