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| Name | Class |
|---|---|
| University of Tromso | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo first | Active Comparator | Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks |
|
| Melatonin first | Active Comparator | Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Drug | Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine attack frequency | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index score | 8 weeks | |
| Night time sleep quality | 8 weeks | |
| Point prevalence of insomnia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Neurology, NLSH HF | Bodø | 8092 | Norway | |||
| Departement of Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15326268 | Background | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 8 weeks |
| Tromsø |
| 9037 |
| Norway |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |