Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model

Conditions
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Migraine

Intervention / Treatment
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* Drug: Placebo
* Drug: Sumatriptan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sumatriptan<br>Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg | Drug: Sumatriptan<br>* Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan<br>|
| Placebo Comparator: Placebo<br>Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo | Drug: Placebo<br>* Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in peak headache score |  | 12 hours |