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The study was terminated prematurely due to poor recruitment.
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| Name | Class |
|---|---|
| King's College London | OTHER |
| University Hospital of North Norway | OTHER |
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Sporadic and chronic dietary consumption of caffeine has substantial biological effects on the nervous system. The effects on migraine are at large not known. In this study we want to assess the effects of caffeine withdrawal on migraine.
The actions of caffeine as an antagonist of adenosine receptors have been extensively studied, and there is no doubt that both daily and sporadic dietary consumption of caffeine has substantial biological effects on the nervous system. The current opinion is that caffeine both can cure and trigger headaches. Caffeine is a component of many combination drugs marketed for the relief of headaches, but on the other hand it is strongly incriminated as a risk factor for developing chronic headache. Withdrawal may cause symptom constellations similar to the migraine syndrome. Further, caffeine consumption may affect sleep and alertness, possibly influencing the risk of migraine attacks. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine | Active Comparator | Caffeine tablets (Recip) 100 mg, 300-800 mg |
|
| Placebo | Placebo Comparator | Placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine days | Reduction from baseline in monthly migraine days (withdrawal vs. caffeine) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal symptoms and/or syndrome (according to criteria) | If patients report withdrawal symptoms, these will be recorded and eventually diagnosed as either caffeine withdrawal symptoms or migraineous symptoms in accordance with international criteria | 2 first days after caffeine withdrawal(withdrawal vs. caffeine) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan T Henriksen | Department for research and patient safety, Nordland Hospital trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordland Hospital | Bodø | 8011 | Norway | |||
| Departement of Neurology, NLSH HF |
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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 |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
| Migraine attacks |
Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine) |
| 10 weeks |
| Sleep improvement | Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine) | 10 weeks |
| Quality of life | Reduction from baseline in HIT-6 (withdrawal vs. caffeine) | 10 weeks |
| Bodø |
| 8092 |
| Norway |
| Departement of Neurology | Tromsø | 9037 | Norway |
| D009422 | Nervous System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |