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To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug candidates.
There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: 5-ISMN induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.
Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sumatriptan | Active Comparator | headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg |
|
| Placebo | Placebo Comparator | headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ISMN (isosorbide-5-mononitrate) | Drug | 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median headache score 0 hours after sumatriptan/placebo | 0 hours | |
| Median headache score 2 hours after sumatriptan/placebo | 2 hours |
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Inclusion Criteria:
Healthy:
Migraine patients:
Exclusion Criteria:
Healthy:
Migraine patients:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Katrine Hansen, Doctor | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emma Katrine Hansen | Copenhagen | Glostrup | 2600 | Denmark |
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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 |
|---|---|
| C030397 | isosorbide-5-mononitrate |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
| Sumatriptan | Drug | 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
|
|
| Placebo | Drug | 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
|
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |