[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559306":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":73,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Responders",null,"Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway (mAbs) who obtained a reduction in monthly migraine days equal or higher than 50% compared to pre-treatment values.",[13],"Drug: MAbs",{"label":15,"type":10,"description":16,"interventionNames":17},"NON-Responders","Patients with high frequency episodic or chronic migraine undergoing mAbs treatment who obtained a reduction in monthly migraine days \\\u003C 50% compared to pre-treatment values.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","MAbs","Monthly or quarterly mAbs administration",[15,9],[25],"Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Roberto De Icco","CONTACT","00390382380425","roberto.deicco@mondino.it",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Cinzia Fattore","00390382380385","cinzia.fattore@mondino.it",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Headache Science & Neurorehabilitation Unit","RECRUITING","Pavia","27100","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],9.15917,45.19205,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":53,"phoneExt":10,"email":31},"Roberto De Icco, Prof","00382380425",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":6},"University of L'Aquila","100559306","searching-for-novel-biological-phenotypes-in-migraine-patients-resistant-to-treatments-100559306",false,"NCT06562413","Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments","Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)","SPHERA_WP1_2","Inclusion Criteria:\n\n* male and female patients aged 18 to 75 years\n* diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria\n* for episodic migraine: 8-14 monthly migraine days in the previous 3 months\n* diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months\n* patients naive to CGRP targeting treatments\n\nExclusion Criteria:\n\n* history of major psychiatric or other neurological conditions\n* diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)\n* changes in ongoing preventive treatment (if any) in the previous 3 months\n* clinically significant medical conditions\n* chronic pain conditions\n* alcohol and\u002For drug abuse\n* pregnancy or lactation","ALL","18 Years","75 Years",{"count":71,"type":72},100,"ESTIMATED","6 Months","OBSERVATIONAL","The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders).\n\nPrimary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \\>\u002F= than 50% (namely Responders) and those who will not (namely Responders).\n\nThe 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).",[77,78,79],"Migraine Disorders","Chronic Migraine","Episodic Migraine",[81,82,83,84,85,86],"migraine","anti CGRP mABs","calcitonin gene related peptide","HD EEG","functional MRI","brain connectivity","2024-08-17",{"date":89,"type":90},"2024-08-20","ACTUAL",{"date":92,"type":90},"2023-05-10",{"date":94,"type":72},"2026-05",{"name":5,"class":6},1]