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To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, 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 Cilostazol, a phosphodiesterase inhibitor 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: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection 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 Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan |
|
| Placebo | Placebo Comparator | headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol 200mg | Drug | Cilostazol 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 |
|---|---|---|
| Difference in median headache score after sumatriptan/placebo | The investigators will assess the outcome measures 1 year after the beginning of the study | 2hours |
| difference in AUC 0-4h post treatment | The difference in area under the curve 0-4h after treatment with sumatriptan and placebo | 4hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32216457 | Derived | Falkenberg K, Bjerg HR, Olesen J. Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. Cephalalgia. 2020 Jul;40(8):842-850. doi: 10.1177/0333102420915166. Epub 2020 Mar 26. |
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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 |
|---|---|
| D000077407 | Cilostazol |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| SUMAtriptan 6 MG/ML | Drug | Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
|
|
| Placebo | Drug | Cilostazol 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 |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |