[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554440":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":55,"interventions":78,"overallOfficials":48,"centralContacts":100,"locations":48,"responsibleParty":110,"collaborators":112,"id":117,"slug":48,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":48,"enrollmentInfo":126,"targetDuration":48,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":139,"whyStopped":48,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":48},{"fullName":5,"class":6},"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the effectiveness of the most frequently used drugs in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.","Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.","12 weeks",[14,17,21,24,27,30,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":12},"Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline)","Proportion of patients responding at 12 weeks from start of treatment; \\\u003C25% change in mean number of MMD: non-responders, 25-49%: partial responders, 50-75%: responders, \\>75%: excellent responders.",{"measure":18,"description":19,"timeFrame":20},"Evaluate effectiveness before completing the clinical trial","Change in mean number of MMDs at 4 and 8 weeks from baseline.","4, 8 and 12 weeks",{"measure":22,"description":23,"timeFrame":20},"Estimate the reduction in the intensity of migraine attacks","Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.",{"measure":25,"description":26,"timeFrame":12},"Estimate the prevalence of symptoms associated with migraine","Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.",{"measure":28,"description":29,"timeFrame":12},"Evaluate adherence to preventive treatment","Proportion of adherent and non-adherent patients (according to taking \\[yes\u002Fno\\] of the study treatment with the prescribed dosage) at 12 weeks from the start of treatment.",{"measure":31,"description":32,"timeFrame":20},"Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others).","Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.",{"measure":34,"description":35,"timeFrame":20},"Evaluate reconsultation visits due to migraine attacks","Reconsultations: Type of consultation (PCC, PC emergency, hospital, hospital emergency). Number of consultations after 12 weeks from the start. Number of medical tests performed relacionadas con la migraña.",{"measure":37,"description":38,"timeFrame":12},"Evaluate improvement in quality of life and patient satisfaction","Change in EQ-5D-5L questionnaire at 12 weeks from baseline. Including Visual Analogue Scale (0-100). Lower scores means worse health condition.",{"measure":40,"description":41,"timeFrame":20},"Analyze the differences between men and women regarding study drugs effectiveness.","Result comparison change in mean number of MMDs adjusted by sex",{"measure":43,"description":44,"timeFrame":12},"Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism.","Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.",{"measure":46,"description":47,"timeFrame":12},"Incidence of adverse events of the four drugs used in the preventive treatment of migraine .","Number of adverse events",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE",[56,62,67,72],{"label":57,"type":58,"description":59,"interventionNames":60},"Topiramate","EXPERIMENTAL","25-100 mg\u002F12h, V.O., during 12 weeks",[61],"Drug: Topiramate",{"label":63,"type":58,"description":64,"interventionNames":65},"Flunarizine","2,5-10 mg\u002F24h, V.O., during 12 weeks",[66],"Drug: Flunarizine",{"label":68,"type":58,"description":69,"interventionNames":70},"Amitriptyline","10-75 mg\u002F24h, V.O., during 12 weeks",[71],"Drug: Amitriptyline",{"label":73,"type":74,"description":75,"interventionNames":76},"Propranolol","ACTIVE_COMPARATOR","20-120 mg\u002F12h, V.O., during 12 weeks",[77],"Drug: Propranolol",[79,85,90,95],{"type":80,"name":57,"description":81,"armGroupLabels":82,"otherNames":83},"DRUG","Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg\u002F12h.",[57],[84],"Acomicil",{"type":80,"name":63,"description":86,"armGroupLabels":87,"otherNames":88},"Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg\u002F24h.",[63],[89],"Sibelium",{"type":80,"name":68,"description":91,"armGroupLabels":92,"otherNames":93},"Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg\u002F24h.",[68],[94],"Tryptizol",{"type":80,"name":73,"description":96,"armGroupLabels":97,"otherNames":98},"Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg\u002F12h.",[73],[99],"Sumial",[101,106],{"name":102,"role":103,"phone":104,"phoneExt":48,"email":105},"Maria Giner-Soriano","CONTACT","+34 93 482 4110","mginer@idiapjgol.info",{"name":107,"role":103,"phone":108,"phoneExt":48,"email":109},"Ana Garcia-Sangenis","+34 93 482 4651","agarcia@idiapjgol.org",{"type":111,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[113,115],{"name":114,"class":6},"Institut Català de la Salut",{"name":116,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","100554440",false,"NCT06499116","Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care","Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]","PREMI","Inclusion Criteria:\n\n\\- Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial.\n\nExclusion Criteria:\n\n* People diagnosed with migraine who are not candidates for preventive migraine treatment\n* People diagnosed with chronic migraine (\\>15 days of headache per month, of which 8 are monthly migraine days)\n* Not having a smartphone\n* Simultaneous participation in another clinical trial\n* Pregnancy or expected pregnancy during the next 3 months\n* Lactation\n* People with migraine who already receive preventive treatment.\n* People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis.\n* People who, in the opinion of the clinician, have an absolute contraindication to one of the study drugs or who cannot perform the trial procedures:\n\nHypersensitivity to any of the study drugs \u002F Heart block or severe bradycardia \u002F Concomitant treatment with verapamil or diltiazem \u002F Active cardiovascular pathology (recent heart attack, angina, Raynaud's phenomenon) \u002F Major depression or active treatment with antidepressants (including monoamine oxidase inhibitors and St. John's wort) \u002F Other psychiatric illnesses or active treatment with antipsychotics or lithium \u002F Severe liver disease or kidney failure \u002F Parkinson's disease or other extrapyramidal disorders \u002F Epilepsy (diagnosis and\u002For active treatment) \u002F Any other contraindication that, in the opinion of the clinician, prevents participation in the clinical trial","ALL","18 Years",{"count":127,"type":128},460,"ESTIMATED","INTERVENTIONAL",[131],"PHASE4","This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.",[134],"Migraine",[134,136,137,138],"Monthly Migraine Days (MMD)","Preventive treatment","Primary care","NOT_YET_RECRUITING","2024-07-08",{"date":142,"type":143},"2024-07-12","ACTUAL",{"date":145,"type":128},"2024-10",{"date":147,"type":128},"2026-12",{"name":5,"class":6}]