Melatonin for Migraine Prevention (MMP)

This study has been completed.
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Karl B. Alstadhaug, Nordlandssykehuset HF
ClinicalTrials.gov Identifier:
NCT00849511
First received: February 23, 2009
Last updated: September 24, 2014
Last verified: September 2014

February 23, 2009
September 24, 2014
February 2009
September 2009   (final data collection date for primary outcome measure)
Migraine attack frequency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00849511 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Melatonin for Migraine Prevention
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Migraine
Drug: melatonin
Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
Other Name: Circadin
  • Active Comparator: Placebo first
    Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks
    Intervention: Drug: melatonin
  • Active Comparator: Melatonin first
    Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
    Intervention: Drug: melatonin
Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00849511
270472
No
Karl B. Alstadhaug, Nordlandssykehuset HF
Nordlandssykehuset HF
University of Tromso
Not Provided
Nordlandssykehuset HF
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP