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Melatonin for Migraine Prevention (MMP)

This study has been completed.
University of Tromso
Information provided by (Responsible Party):
Karl B. Alstadhaug, Nordlandssykehuset HF Identifier:
First received: February 23, 2009
Last updated: September 24, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Migraine Drug: melatonin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Melatonin for Migraine Prevention (The MMP-study): A Randomized, Double-blind, Cross-over, Placebo-controlled Study of Melatonin in Prophylactic Treatment of Migraine

Resource links provided by NLM:

Further study details as provided by Karl B. Alstadhaug, Nordlandssykehuset HF:

Primary Outcome Measures:
  • Migraine attack frequency [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo first
Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks
Drug: melatonin
Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
Other Name: Circadin
Active Comparator: Melatonin first
Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
Drug: melatonin
Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
Other Name: Circadin


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00849511

Departement of Neurology, NLSH HF
Bodø, Norway, 8092
Departement of Neurology
Tromsø, Norway, 9037
Sponsors and Collaborators
Nordlandssykehuset HF
University of Tromso
  More Information

Responsible Party: Karl B. Alstadhaug, MD, PhD, Nordlandssykehuset HF Identifier: NCT00849511     History of Changes
Other Study ID Numbers: 270472
Study First Received: February 23, 2009
Last Updated: September 24, 2014

Keywords provided by Karl B. Alstadhaug, Nordlandssykehuset HF:
Migraine prevention

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on August 16, 2017