The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Cilostazol 200mg
* Drug: SUMAtriptan 6 MG/ML
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-70 years 45-95 kg. Exclusion Criteria: Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 treated double-blinded with 6mg/ml sumatriptan | Drug: Cilostazol 200mg<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>* Other names: Pletal;Drug: SUMAtriptan 6 MG/ML<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>* Other names: Imigran;|
| Placebo Comparator: Placebo<br>headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb | Drug: Cilostazol 200mg<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>* Other names: Pletal;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?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |