Melatonin for Migraine Prevention (MMP)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Nordlandssykehuset HF.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

University of Tromso

Information provided by:

Nordlandssykehuset HF

ClinicalTrials.gov Identifier:

NCT00849511

First received: February 23, 2009

Last updated: September 17, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 23, 2009
Last Updated Date	September 17, 2009
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2009)	Migraine attack frequency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00849511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 23, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Melatonin for Migraine Prevention
Official Title ^ICMJE	Melatonin for Migraine Prevention (The MMP-study): A Randomized, Double-blind, Cross-over, Placebo-controlled Study of Melatonin in Prophylactic Treatment of Migraine
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Drug: melatonin Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
Study Arm (s)	Not Provided
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	53
Estimated Completion Date	October 2009
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT00849511
Other Study ID Numbers ^ICMJE	270472
Has Data Monitoring Committee	No
Responsible Party	Karl B. Alstadhaug, Department of Neurology, NLSH HF
Study Sponsor ^ICMJE	Nordlandssykehuset HF
Collaborators ^ICMJE	University of Tromso
Investigators ^ICMJE	Not Provided
Information Provided By	Nordlandssykehuset HF
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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