Melatonin for Migraine Prevention (MMP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Nordlandssykehuset HF.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Tromso
Information provided by:
Nordlandssykehuset HF
ClinicalTrials.gov Identifier:
NCT00849511
First received: February 23, 2009
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Nordlandssykehuset HF:

Primary Outcome Measures:
  • Migraine attack frequency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pittsburgh Sleep Quality Index score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Night time sleep quality [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Point prevalence of insomnia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: February 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: melatonin
    Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849511

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

Publications:
Responsible Party: Karl B. Alstadhaug, Department of Neurology, NLSH HF
ClinicalTrials.gov Identifier: NCT00849511     History of Changes
Other Study ID Numbers: 270472
Study First Received: February 23, 2009
Last Updated: September 17, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

Keywords provided by Nordlandssykehuset HF:
Migraine prevention
Crossover
Melatonin

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014