[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100410739":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":42,"centralContacts":46,"locations":52,"responsibleParty":67,"collaborators":10,"id":70,"slug":10,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Episodic Migraine",null,"All patients who have been diagnosed with migraine without aura or migraine with aura according to the diagnostic criteria of the International Classification of Headache Disorders, third edition (ICHD-3) and have been unsuccessfully treated with first-line prophylactic medication",[13,14,15],"Drug: Erenumab","Drug: Galcanezumab","Drug: Fremanezumab",{"label":17,"type":10,"description":18,"interventionNames":19},"Chronic Migraine","All patients who have been diagnosed with chronic migraine (≥15 headache days per month 8 of which with migrainous features) according to the diagnostic criteria of the International Classification of Headache Disorders, third edition (ICHD-3) and have been unsuccessfully treated with first-line prophylactic medication",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":10},"Healthy Control","Controls must be healthy (free of any diagnosed chronic disease, acute infection requiring medication, family history or personal history of migraine), chosen to be as similar as possible to migraine patients, in terms of age and sex.",[24,31,37],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Erenumab","anti-CGRP-receptor monoclonal anti-body",[17,9],[30],"Aimovig®",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Galcanezumab","anti-CGRP-ligand monoclonal anti-body",[17,9],[36],"Emgality®",{"type":25,"name":38,"description":33,"armGroupLabels":39,"otherNames":40},"Fremanezumab",[17,9],[41],"Ajovy®",[43],{"name":44,"affiliation":5,"role":45},"Christian Wöber, Prof. MD","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Antun R Pavelic, MD","CONTACT","+43 (0)1 40400 - 31170","antun.pavelic@meduniwien.ac.at",[53],{"facility":5,"status":54,"city":55,"state":10,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Vienna","1090","Austria","AT",{"type":60,"coordinates":61},"Point",[62,63],16.37208,48.20849,{"lat":63,"lon":62},[66],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},{"type":45,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Christian Wöber, MD","Associate Professor","100410739",false,"NCT04628429","CGRP Inhibition, Autonomic Function, and Migraine","Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition","CGRP-1","Inclusion Criteria:\n\n* Chronic migraine according to ICHD-3\n* Episodic migraine without aura or with aura according to ICHD-3\n* Unsuccessful treatment with 3 or more established prophylactic drugs\n* Medicine costs are covered by health insurance\n* Healthy controls must be free from any diagnosed chronic disease or acute infection requiring medication\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Neurosurgical interventions performed within the last 12 months\n* Coronary bypass surgery or revascularization procedures performed within the last 12 months\n* History of transient ischemic attacks (TIA), stroke, stable or unstable angina pectoris, myocardial infarction or uncontrolled hypertension\n* Known hypersensitivity to therapy with an anti-CGRP Antibodies\n* History of a disorder (other than migraine) that may affect the results of autonomic tests\n* Healthy controls must have no personal or family history of migraine",true,"ALL","18 Years","64 Years",{"count":82,"type":83},120,"ESTIMATED","OBSERVATIONAL","The purpose of this clinical study is to better understand the function of the autonomic nervous system in patients with migraine. We aim to understand whether the autonomic functions change depending on the migraine status (i.e. whether they are between or during attacks) and whether the CGRP monoclonal antibody (mAb) class of drugs affects the autonomic functions. The aim is not to investigate the effect of CGRP-mAb on migraine frequency. Calcitonin gene-related peptide (CGRP) is a neurotransmitter in the nervous system that plays an essential role in the development of migraine headache. Monoclonal antibodies can block the function of this messenger substance. Several studies have shown that this blockade leads to a reduction in the frequency of migraine.\n\nIn addition to its role in migraine, CGRP also acts on the blood vessels and the autonomic nervous system. The autonomic nervous system is responsible for everything we have no control over in our body. This includes everything from heart rate and blood pressure to our digestion.",[9,17],[88,89,90,91,92,93,94,95],"Calcitonin gene-related peptide inhibition","Monoclonal antibodies","Autonomic function","Composite Autonomic Symptom Scale 31","Migraine Disability Assessment Scale","Depression Anxiety Stress Scales","Cardiovascular Autonomic Dysfunction","Headache Impact Questionnaire","2024-12-07",{"date":98,"type":99},"2024-12-10","ACTUAL",{"date":101,"type":99},"2020-10-01",{"date":103,"type":83},"2026-12",{"name":5,"class":6},1]