Back to resultsMelatonin for Migraine Prevention (MMP)
Primary Purpose
Migraine
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
melatonin
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring Migraine prevention, Crossover, Melatonin
Eligibility Criteria
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.
Sites / Locations
- Departement of Neurology, NLSH HF
- Departement of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Placebo first
Melatonin first
Arm Description
Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks
Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
Outcomes
Primary Outcome Measures
Migraine attack frequency
Secondary Outcome Measures
Pittsburgh Sleep Quality Index score
Night time sleep quality
Point prevalence of insomnia
Full Information
NCT ID
NCT00849511
First Posted
February 23, 2009
Last Updated
September 24, 2014
Sponsor
Nordlandssykehuset HF
Collaborators
University of Tromso
1. Study Identification
Unique Protocol Identification Number
NCT00849511
Brief Title
Melatonin for Migraine Prevention
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordlandssykehuset HF
Collaborators
University of Tromso
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine prevention, Crossover, Melatonin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo first
Arm Type
Active Comparator
Arm Description
Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks
Arm Title
Melatonin first
Arm Type
Active Comparator
Arm Description
Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
Intervention Type
Drug
Intervention Name(s)
melatonin
Other Intervention Name(s)
Circadin
Intervention Description
Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
Primary Outcome Measure Information:
Title
Migraine attack frequency
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index score
Time Frame
8 weeks
Title
Night time sleep quality
Time Frame
8 weeks
Title
Point prevalence of insomnia
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Departement of Neurology, NLSH HF
City
Bodø
ZIP/Postal Code
8092
Country
Norway
Facility Name
Departement of Neurology
City
Tromsø
ZIP/Postal Code
9037
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
15326268
Citation
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.
Results Reference
background
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Melatonin for Migraine Prevention
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