Melatonin for Migraine Prevention (MMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849511
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : September 25, 2014
University of Tromso
Information provided by (Responsible Party):
Karl B. Alstadhaug, Nordlandssykehuset HF

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: melatonin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Study Start Date : February 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849511

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

Responsible Party: Karl B. Alstadhaug, MD, PhD, Nordlandssykehuset HF Identifier: NCT00849511     History of Changes
Other Study ID Numbers: 270472
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 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