[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559305":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":34,"locations":44,"responsibleParty":60,"collaborators":62,"id":65,"slug":10,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":78,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"NON-Responders",null,"Patients with high frequency episodic or chronic migraine who obtained a reduction in monthly migraine days \\\u003C 50% after three months of mAbs treatment compared to pre-treatment values.",[13,14],"Dietary Supplement: Palmitoyl ethanolamide","Behavioral: Ketogenic diet",{"label":16,"type":10,"description":17,"interventionNames":18},"Partial-Responders","Patients with high frequency episodic or chronic migraine who obtained a reduction in monthly migraine days \\> or equal to 50% after six months of mAbs treatment compared to pre-treatment values but still present more than 5 MMDs.",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Palmitoyl ethanolamide","PEA supplementation (600mg twice a day for three months)",[9,16],[26],"PEA",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Ketogenic diet","Diet characterized by the following percentages of macronutrients: 65% fat, 27% protein and 8% carbohydrates",[9],[33],"KD",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Roberto De Icco","CONTACT","00390382380425","roberto.deicco@mondino.it",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Cinzia Fattore","00390382380385","cinzia.fattore@mondino.it",[45],{"facility":46,"status":47,"city":48,"state":10,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Headache Science & Neurorehabilitation Unit","RECRUITING","Pavia","27100","Italy",{"type":52,"coordinates":53},"Point",[54,55],9.15917,45.19205,{"lat":55,"lon":54},[58],{"name":36,"role":37,"phone":59,"phoneExt":10,"email":39},"00382380425",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[63],{"name":64,"class":6},"University of L'Aquila","100559305",false,"NCT06562400","Searching for Novel Therapeutic Approaches 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_WP2","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* clinically significant medical conditions\n* chronic pain conditions\n* alcohol and\u002For drug abuse\n* pregnancy or lactation","ALL","18 Years","75 Years",{"count":76,"type":77},45,"ESTIMATED","6 Months","OBSERVATIONAL","Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group.\n\nThey will be identified as patients showing a reduction of monthly migraine days \\\u003C 50% after three months of treatment.\n\nThe clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients",[82,83,84],"Migraine Disorders","Chronic Migraine","Episodic Migraine",[86,87,88,89,90,91,92,93],"migraine","anti CGRP mABs","calcitonin gene related peptide","endocannabinoid system","HD EEG","functional MRI","brain connectivity","miocrobiome","2024-08-17",{"date":96,"type":97},"2024-08-20","ACTUAL",{"date":99,"type":97},"2023-05-10",{"date":101,"type":77},"2026-05",{"name":5,"class":6},1]