Melatonin for Migraine Prevention

Migraine Clinical Trial

— MMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849511
• Other study ID #: 270472
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2009
• Last updated: September 24, 2014
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: September 2014
• Source: Nordlandssykehuset HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• melatonin
Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks

Locations

Country	Name	City	State
Norway	Departement of Neurology, NLSH HF	Bodø
Norway	Departement of Neurology	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine attack frequency		8 weeks	No
Secondary	Pittsburgh Sleep Quality Index score		8 weeks	No
Secondary	Night time sleep quality		8 weeks	No
Secondary	Point prevalence of insomnia		8 weeks	No