MigrainePhase 2MMPNCT00849511
Melatonin for Migraine Prevention
A Phase 2 study testing melatonin in people with Migraine, run by Nordlandssykehuset HF at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2009to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Departement of Neurology, NLSH HF
Bodø, 8092
Departement of Neurology
Tromsø, 9037
About this study
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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
Also called Circadin
Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo first | Active comparator | Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks Receives: Drug: melatonin |
| Melatonin first | Active comparator | Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks Receives: Drug: melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine attack frequency
Measured: 8 weeks
Secondary outcomes (3)
Pittsburgh Sleep Quality Index score
Measured: 8 weeks
Night time sleep quality
Measured: 8 weeks
Point prevalence of insomnia
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Karl B. Alstadhaug, Nordlandssykehuset HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849511
- Sponsor's protocol ID
- 270472
- Acronym
- MMP
- Status last verified
- Sep 2014
- First submitted
- 23 Feb 2009
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.
PubMed 15326268
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00849511
- Acronym / sponsor ID
- MMP / 270472
- Conditions
- Migraine
- Keywords
- Migraine prevention, Crossover, Melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo first | Active comparator | Drug: melatoninPlacebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks |
| Melatonin first | Active comparator | Drug: melatoninExtended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninAlso: CircadinCircadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks | Drug | Melatonin first, Placebo first |
Primary outcome
Migraine attack frequency
Time frame: 8 weeks
3 secondary outcomes
Pittsburgh Sleep Quality Index score
Time frame: 8 weeks
Night time sleep quality
Time frame: 8 weeks
Point prevalence of insomnia
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Background: PubMed 15326268Peres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melatonin in people with Migraine, run by Nordlandssykehuset HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine attack frequency (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00849511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.