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Completed

NCT Number: NCT00849511

Melatonin for Migraine Prevention

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Departement of Neurology, NLSH HF, Bodø, Norway

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

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

Other names: Circadin

Primary outcomes

  1. Migraine attack frequency

    Time frame: 8 weeks

Secondary outcomes

  1. Pittsburgh Sleep Quality Index score

    Time frame: 8 weeks

  2. Night time sleep quality

    Time frame: 8 weeks

  3. Point prevalence of insomnia

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Nordlandssykehuset HF

Other

Collaborators

  • University of Tromso

Registry information

Official study title

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

Acronym: MMP

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 24, 2009
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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