protocolSection identificationModule nctId: NCT06267664, orgStudyIdInfo id: PI-GR-23-3263, briefTitle: Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP), acronym: TRIDIGEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Hospital Clínico Universitario de Valladolid, class: OTHER, descriptionModule briefSummary: Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes., conditionsModule conditions: Migraine, conditions: Migraine Disorders, conditions: Migraine With Aura, conditions: Headache Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Patients with migraine treated with triptans, Lasmiditan or Gepants, outcomesModule primaryOutcomes measure: Pain freedom at 2 hours, primaryOutcomes measure: Absence of the most bothersome symptom, secondaryOutcomes measure: Pain freedom at 8 hours, secondaryOutcomes measure: Pain freedom at 24 hours, secondaryOutcomes measure: Sustained pain freedom, secondaryOutcomes measure: Total freedom from migraine at 2 hours, secondaryOutcomes measure: Total freedom from migraine at 8 hours, secondaryOutcomes measure: Total freedom from migraine at 24 hours, secondaryOutcomes measure: Headache relief at 2 hours, secondaryOutcomes measure: Headache relief at 8 hours, secondaryOutcomes measure: Headache relief at 24 hours, secondaryOutcomes measure: Time to meaningful relief, secondaryOutcomes measure: Time to pain freedom, secondaryOutcomes measure: Time to migraine freedom, secondaryOutcomes measure: Need of rescue medication at 2 hours, secondaryOutcomes measure: Need of rescue medication at 8 hours, secondaryOutcomes measure: Need of rescue medication at 24 hours, secondaryOutcomes measure: Tolerability of the drugs, secondaryOutcomes measure: Response predictors at 2 hours, secondaryOutcomes measure: Response predictors at 24 hours, secondaryOutcomes measure: Tolerability predictors, secondaryOutcomes measure: Time lost due to an attack, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Valladolid, status: RECRUITING, city: Valladolid, zip: 47010, country: Spain, contacts name: David Garcia Azorin, MD, PhD, role: CONTACT, phone: +34665872228, email: davilink@hotmail.com, contacts name: Yesica González Osorio, role: CONTACT, phone: 634330426, email: yesgonzalezosorio@outlook.com, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False