The Effect of Sumatriptan and Placebo on CGRP Induced Headache

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 and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). 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 Calcitonine Gene Related Peptide (CGRP) 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: CGRP 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.

Official Title
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The Effect of Sumatriptan and Placebo on CGRP Induced Headache

Conditions
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Migraine

Intervention / Treatment
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* Drug: Calcitonin Gene Related Peptide
* Drug: Sumatriptan 50 mg
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy: Healthy subjects of both sexes Age 18-60 years Weight 45-95 kg. Females were requested to use effective contraception. Migraine patients: Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg. Exclusion Criteria: Healthy: 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). Migraine patients: 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
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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 CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment | Drug: Calcitonin Gene Related Peptide<br>* CGRP 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: CGRP;Drug: Sumatriptan 50 mg<br>* CGRP 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 CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment | Drug: Calcitonin Gene Related Peptide<br>* CGRP 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: CGRP;Drug: Placebo Oral Tablet<br>* CGRPis 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 |
| --- | --- | --- |
| AUC after infusion | The investigators will assess the outcome measures 1 year after the beginning of the study | 1 year |