[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559305":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":34,"locations":44,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"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,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Headache Science & Neurorehabilitation Unit","RECRUITING","Pavia","27100","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],9.15917,45.19205,{"lat":56,"lon":55},[59],{"name":36,"role":37,"phone":60,"phoneExt":10,"email":39},"00382380425",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64],{"name":65,"class":6},"University of L'Aquila","100559305","searching-for-novel-therapeutic-approaches-in-migraine-patients-resistant-to-treatments-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":78,"type":79},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",[84,85,86],"Migraine Disorders","Chronic Migraine","Episodic Migraine",[88,89,90,91,92,93,94,95],"migraine","anti CGRP mABs","calcitonin gene related peptide","endocannabinoid system","HD EEG","functional MRI","brain connectivity","miocrobiome","2024-08-17",{"date":98,"type":99},"2024-08-20","ACTUAL",{"date":101,"type":99},"2023-05-10",{"date":103,"type":79},"2026-05",{"name":5,"class":6},1]