Melatonin for Migraine Prevention (MMP)

September 24, 2014 updated by: Karl B. Alstadhaug, Nordlandssykehuset HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bodø, Norway, 8092
        • Departement of Neurology, NLSH HF
      • Tromsø, Norway, 9037
        • Departement of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Circadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Migraine attack frequency
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordlandssykehuset HF

Collaborators

University of Tromso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 270472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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