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To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. 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 Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO).
To validate cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with 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 Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg |
|
| Placebo | Placebo Comparator | Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in median headache score 2 hours after cilostazol | The investigators will assess the outcome measures 1 year after the beginning of the study | 2 hours |
| Area under the headache score curve | The investigators will assess the outcome measures 1 year after the beginning of the study | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in peak headache score | 12 hours |
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Inclusion Criteria:
Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.
Exclusion Criteria:
Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katrine Falkenberg | Copenhagen | Glostrup | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30120600 | Derived | Falkenberg K, Olesen J. Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers. J Headache Pain. 2018 Aug 17;19(1):71. doi: 10.1186/s10194-018-0890-y. |
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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 |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Sumatriptan | 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 |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |