[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582872":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":45,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"IRCCS San Raffaele Roma","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Migraineurs with >4 monthly migraine days",null,"Consecutive adults with episodic migraine (EM) or chronic migraine (CM) with more than 4 days of migraine per month who attend Headache Centers and have been prescribed at least one dose of sumatriptan 85 mg in combination with naproxen 500 mg for the acute treatment of migraine will be enrolled.",[13],"Drug: combination of sumatriptan 85 mg and naproxen 500 mg",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","combination of sumatriptan 85 mg and naproxen 500 mg",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Piero Barbanti, MD, PhD","CONTACT","+393357071457","piero.barbanti@sanraffaele.it",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Cinzia Aurilia, MD","3334147390","cinzia.aurilia@sanraffaele.it",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100582872","use-of-the-combination-of-sumatriptan-and-naproxen-in-the-acute-treatment-of-migraine-real-world-evidence-study-100582872",false,"NCT06868953","Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study","SMART","Inclusion Criteria:\n\n1. Migraineurs (age ≥18 years, \\\u003C65 years) with at least 4 migraine days per month according to ICHD-3 criteria who have been prescribed the combination of sumatriptan 85 mg and naproxen 500 mg;\n2. Signed informed consent as required;\n3. Agreement to comply with all study procedures, including follow-up visits;\n4. Use of a contraceptive method by all participants throughout the study duration.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years or \\>65 years\n2. Pregnancy or breastfeeding\n3. Poor knowledge of the Italian language\n4. Comorbidities with other neurological, cardiovascular, hepatic, respiratory, hematological, or autoimmune diseases, or clinically significant laboratory abnormalities\n5. Inability to distinguish migraine attacks from tension-type headaches\n6. Migraine characterized by mild attacks or attacks that resolve spontaneously within 2 hours\n7. Hemiplegic or basilar migraine\n8. Headache with the use of acute medication on more than 10 days per month in each of the 3 months prior to screening\n9. Unwillingness to participate in the study -",true,"ALL","18 Years","65 Years",{"count":43,"type":44},300,"ESTIMATED","6 Months","OBSERVATIONAL","This is a multicenter, observational, prospective, real-life study that will be conducted at Headache Centers, aimed at confirming the efficacy and safety of the combination of sumatriptan 85 mg with naproxen 500 mg. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks, with or without aura, in adult patients for whom sumatriptan monotherapy is insufficient. In two randomized studies, the sumatriptan\u002Fnaproxen sodium combination demonstrated significantly greater efficacy (65% of participants-n=1461-reported pain freedom at 2 hours) compared to sumatriptan alone (55%), naproxen sodium alone (44%), or placebo (28%) when used as a late therapy for a single migraine episode in adults. Similar results were observed in a second study (n=1495), with 57% of participants achieving pain freedom within 2 hours after taking the sumatriptan\u002Fnaproxen sodium combination, outperforming both sumatriptan monotherapy (50%) and naproxen sodium monotherapy (43%), as well as placebo (29%). This superiority was further assessed through sustained pain freedom over 24 hours, with an efficacy of 23-25% in participants treated with the sumatriptan\u002Fnaproxen combination compared to placebo (7-8%; p\\\u003C0.001 for both studies) and its individual components (sumatriptan monotherapy: 14%-16%; p=0.009 and p\\\u003C0.001, naproxen sodium monotherapy: 10%).\n\nIn four additional randomized studies, the combination was also found to be effective in menstrual migraine and dysmenorrhea, as well as in cases of poor response or intolerance to triptan therapy. In clinical trials, sumatriptan\u002Fnaproxen sodium was generally well tolerated, with an overall safety profile similar to that of sumatriptan. The most common adverse events were consistent with those expected for sumatriptan and naproxen sodium.",[49],"Migraine",[51],"migraine attack","NOT_YET_RECRUITING","2025-03-07",{"date":55,"type":56},"2025-03-11","ACTUAL",{"date":58,"type":44},"2025-04-10",{"date":60,"type":44},"2026-12-31",{"name":5,"class":6}]