[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583883":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HFEM group",null,"High-frequency episodic migraine patients (8-14 migraine days per months) undergoing atogepant 60 mg daily for 3 months",[13],"Drug: Atogepant 60 mg",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Atogepant 60 mg","Atogepant 60 mg daily for 3 months",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Francescantonio Cammarota, MD","CONTACT","00390382380425","francesco.cammarota@mondino.it",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Cinzia Fattore","00390382380385","cinzia.fattore@mondino.it",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Headache Science & Neurorehabilitation Center","RECRUITING","Pavia","PAVIA","27100","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],9.15917,45.19205,{"lat":43,"lon":42},[46,48,49,51],{"name":47,"role":23,"phone":24,"phoneExt":10,"email":25},"Francescantonio Cammarota",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},{"name":22,"role":50,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Roberto De Icco, MD, PhD","SUB_INVESTIGATOR",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100583883","neurophysiological-and-biomolecular-effects-of-atogepant-in-episodic-migraine-100583883",false,"NCT06882122","Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine","Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)","ATOM","Inclusion Criteria:\n\n* Individuals aged between 18 and 70;\n* Diagnosis of episodic migraine according to ICHD-3 criteria;\n* Monthly migraine days between 8 and 14 (high-frequency episodic migraine pattern) in the 3 months before screening;\n* Individuals naïve to CGRP-targeted treatments;\n* No more than one ongoing migraine preventive treatment with a stable dose for at least 3 months.\n\nExclusion Criteria:\n\n* Contraindications to atogepant;\n* History of serious psychiatric conditions;\n* Diagnosis of other primary or secondary headaches (only sporadic tension-type headache is allowed);\n* Medical conditions considered clinically significant by the investigator;\n* Chronic pain conditions that need chronic treatment;\n* Abuse of alcohol and\u002For drugs;\n* Pregnancy or breastfeeding.","ALL","18 Years","70 Years",{"count":68,"type":69},30,"ESTIMATED","OBSERVATIONAL","The investigators aim to assess and compare neurophysiological and biochemical changes induced by a 3-month treatment with atogepant (60 mg daily) in patients with high-frequency episodic migraine (8-14 monthly migraine days). Evaluations will include neurophysiological assessments (High-Density EEG, nociceptive reflexes, and visual evoked potentials) and biomolecular profiling (gene expression of endocannabinoid catabolizing enzymes, CGRP and PACAP plasma levels, and headache-specific microRNAs). Outputs will contribute to defining predictors of atogepant response, elucidating its effects on brain connectivity, excitability, and CGRP\u002Fendocannabinoid pathways, and identifying alternative therapeutic targets for non-responders.",[73,74],"Migraine Disorder","Episodic Migraine",[76,77,78,79,80,81,82],"Migraine","Gepants","endocannabinoid system","MicroRNAs","Habituation deficit","Central sensitization","Functional Connectivity","2025-03-11",{"date":85,"type":86},"2025-03-18","ACTUAL",{"date":88,"type":86},"2024-12-01",{"date":90,"type":69},"2026-04",{"name":5,"class":6},1]