Calcitonin Gene-related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA)

Study Overview
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Brief Summary
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The aim of the present study is to explore the importance of migraine phenotype on the headache/migraine responses after CGRP in FHM-patients, MA-patients and healthy volunteers.

Detailed Description
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Calcitonin gene-related peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in a large proportion of migraine sufferers. Treatment of spontaneous migraine attacks with an inhibitor of CGRP is effective in many patients. These data show that CGRP is involved in migraine pathophysiology. The importance of migraine genetics is disputed. Evidence from FHM patients with known mutations indicates that migraine pathways in FHM may be different from normal migraine. The aim of the present study is to examine whether this difference also exists in FHM patients without known mutations. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Official Title
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CGRP-induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls

Conditions
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Familial Hemiplegic Migraine, Migraine With Aura, Healthy

Intervention / Treatment
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* Drug: CGRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) Diagnosis of migraine with aura(IHS-classification criteria) Healthy controls Exclusion Criteria: Patients and controls: A history of cerebrovascular disease and other CNS- disease A history of serious somatic and mental disease A history suggesting ischaemic heart disease A history of hypo- or hypertension Daily intake of medication apart from oral contraceptives Abuse of alcohol or medicine (opioid analgesics). Pregnant or breastfeeding women. On the study day: No intake of a simple analgesic in the previous 48 hours No headache in the previous 48 hours
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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MA-patients | Drug: CGRP<br>* CGRP (0.5 ug/min) infused intravenously over 20 min<br>|
| Experimental: 2<br>FHM-patients | Drug: CGRP<br>* CGRP (0.5 ug/min) infused intravenously over 20 min<br>|
| Active Comparator: 3<br>Healthy controls | Drug: CGRP<br>* CGRP (0.5 ug/min) infused intravenously over 20 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine and associated symptoms |  | 0-14 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine aura |  | 0 - 14 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FHM, MA, healthy controls, CGRP