Melatonin for Migraine Prevention

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: melatonin

• Registration Number: NCT00849511
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-24
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Melatonin first	melatonin	Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
Placebo first	melatonin	Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks

Primary Outcome Measures

Name	Time	Method
Migraine attack frequency	8 weeks

Secondary Outcome Measures

Name	Time	Method
Night time sleep quality	8 weeks
Pittsburgh Sleep Quality Index score	8 weeks
Point prevalence of insomnia	8 weeks

Trial Locations

Locations (2)

Departement of Neurology, NLSH HF; 🇳🇴 Bodø, Norway

Departement of Neurology; 🇳🇴 Tromsø, Norway