NCT00849511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

February 23, 2009

Last Update Submit

September 24, 2014

Conditions

Migraine

Keywords

Migraine preventionCrossoverMelatonin

Outcome Measures

Primary Outcomes (1)

  • Migraine attack frequency

    8 weeks

Secondary Outcomes (3)

  • Pittsburgh Sleep Quality Index score

    8 weeks

  • Night time sleep quality

    8 weeks

  • Point prevalence of insomnia

    8 weeks

Study Arms (2)

Placebo first

ACTIVE COMPARATOR

Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks

Drug: melatonin

Melatonin first

ACTIVE COMPARATOR

Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks

Drug: melatonin

Interventions

melatoninDRUG

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

Also known as: Circadin
Melatonin firstPlacebo first

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departement of Neurology, NLSH HF

Bodø, 8092, Norway

Location

Departement of Neurology

Tromsø, 9037, Norway

Location

Related 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. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.

    PMID: 15326268BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

NO(2)