Melatonin for Migraine Prevention (The MMP-study): A Randomized, Double-blind, Cross-over, Placebo-controlled Study of Melatonin in Prophylactic Treatment of Migraine
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Nordlandssykehuset HF
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Migraine attack frequency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Placebo first
Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks
Intervention: melatonin (Drug)
Melatonin first
Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
Intervention: melatonin (Drug)
Outcomes
Primary Outcomes
Migraine attack frequency
Time Frame: 8 weeks
Secondary Outcomes
- Night time sleep quality(8 weeks)
- Pittsburgh Sleep Quality Index score(8 weeks)
- Point prevalence of insomnia(8 weeks)
Investigators
Karl B. Alstadhaug
MD, PhD
Nordlandssykehuset HF