Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 7:17 AM
Study NCT ID:
NCT07159750
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077221', 'term': 'Calcitonin Gene-Related Peptide Receptor Antagonists'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-23', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Monthly Headache Days and Monthly Migraine Days', 'timeFrame': 'Through study completion, an average of 2 years'}], 'secondaryOutcomes': [{'measure': 'HIT-6', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.'}, {'measure': 'MIDAS', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine.'}, {'measure': 'PGIC', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'PGIC (Patien Global Impression of Change) scale will be used to assess impression of change in migraine patients.'}, {'measure': 'BAI', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.'}, {'measure': 'BDI-II', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': "Change in BDI-II (Beck's Depression Inventory, 2nd version) scale, to assess depression in migraine patients."}, {'measure': 'MSQ Version 2.1', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': "Changes in MSQ (Migraine-Specific Quality-of-Life) Version 2.1 scale, to assess patient's quality of life."}, {'measure': 'WPAI', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Changes in WPAI (Work Productivity and Activity Impairment) questionnaire, to assess how migraine impacts in work and productivity in migraine patients.'}, {'measure': 'ISI', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients.'}, {'measure': 'ASC-12', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients.'}, {'measure': 'm-TOQ', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'm-TOQ (Migraine Treatment Optimization Questionnaire) scale will be used to assess the effectiveness of migraine treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Prevention', 'Chronic Migraine', 'Episodic Migraine', 'galcanezumab', 'erenumab', 'fremanezumab', 'eptinezumab', 'rimegepant', 'atogepant'], 'conditions': ['Migraine', 'Episodic Migraine', 'Chronic Migraine, Headache']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate clinical differences in patients who received preventive treatment with medication targeting calcitonin gene-related peptide (CGRP) or its receptor: monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) during a 2-year period observation phase.', 'detailedDescription': 'It is a 2-year, multicenter observational study. Patients who meet reimbursement criteria according to local regulations and willing to participate in the study will be included. Monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) will be started and baseline assessment will be conducted. There will be visits every 6 months to assess effectiveness, side-effects, PROMs, and elegibility to continue with the study drug. The observation of patients will last 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Episodic and chronic migraine patients.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Migraine diagnosis according to ICHD-III.\n* Prescription of erenumab, galcanezumab, fremanezumab, eptinezumab, atogepant or rimegepant according to prescriptor criteria and reimbursement criteria according to local regulations.\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Presence of headache different from migraine.\n* Active severe psychiatric condition or cognitive impairment which may affect the ability to consent patient's participation in the study."}, 'identificationModule': {'nctId': 'NCT07159750', 'acronym': 'EUREkA', 'briefTitle': 'Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine', 'orgStudyIdInfo': {'id': 'EOM(AG)008/2024(6234)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine Patients', 'description': 'Migraine patients who initiate a CGRP-targeted treatment', 'interventionNames': ['Drug: CGRP antibody or gepant']}], 'interventions': [{'name': 'CGRP antibody or gepant', 'type': 'DRUG', 'description': 'Patients will start anti-CGRP or its receptor antibody or gepants', 'armGroupLabels': ['Migraine Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Teshamae S Monteith', 'role': 'CONTACT', 'email': 'tmonteith@med.miami.edu', 'phone': '305-243-2010'}], 'facility': 'University of Miami, Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'María Teresa Goicochea, MD', 'role': 'CONTACT', 'email': 'mtgoycochea@fleni.org.ar', 'phone': '(+54) 11 5777-3200'}], 'facility': 'FLENI', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Javiera Canales', 'role': 'CONTACT', 'email': 'javieracanalesrodriguez@gmail.com', 'phone': '(+56) 2 2633 2051'}], 'facility': 'Pontificia Universidad Católica de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Medellín', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Natalia Hernández', 'role': 'CONTACT', 'email': 'hernandez.natalia12@gmail.com', 'phone': '(+57) 304 6452119'}], 'facility': 'Neuromedica', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Rovinj', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Matija Sošić', 'role': 'CONTACT', 'email': 'matija.sosic1@gmail.com', 'phone': '(+385) 52 811 011'}], 'facility': 'Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno', 'geoPoint': {'lat': 45.08268, 'lon': 13.63457}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bianca Raffaelli', 'role': 'CONTACT', 'email': 'bianca.raffaelli@charite.de', 'phone': '(+49) 30 45050'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ruth Ruscheweyh', 'role': 'CONTACT', 'email': 'ruth.ruscheweyh@med.uni-muenchen.de', 'phone': '(+49) 89 440073800'}], 'facility': 'LMU University Hospital', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'L’Aquila', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Sacco', 'role': 'CONTACT', 'email': 'simona.sacco@univaq.it', 'phone': '(+39) 0862 4311'}], 'facility': "University of L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Iannone', 'role': 'CONTACT', 'email': 'iannone.luigifrancesco@gmail.com', 'phone': '(+39) 059 205 6511'}], 'facility': 'University of Modena and Reggio Emilia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Tassorelli', 'role': 'CONTACT', 'email': 'cristina.tassorelli@unipv.it', 'phone': '(+39) 0382 3801'}], 'facility': 'National Neurological Institute C. Mondino Foundation', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Barbanti', 'role': 'CONTACT', 'email': 'piero.barbanti@sanraffaele.it', 'phone': '(+39) 06 660581'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Serdang', 'state': 'Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Wan Aliaa Wan Sulaiman, FRCP', 'role': 'CONTACT', 'email': 'wanaliaa@upm.edu.my', 'phone': '(+60) 3-9769 1000'}], 'facility': 'Universiti Putra Malaysia', 'geoPoint': {'lat': 3.03333, 'lon': 101.71667}}, {'city': 'Lillestrøm', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Christina Sundal, MD, PhD', 'role': 'CONTACT', 'email': 'christinahsundal@gmail.com', 'phone': '(+47) 97 30 00 05'}], 'facility': 'Neuroclinic Norway', 'geoPoint': {'lat': 59.95597, 'lon': 11.04918}}, {'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marta Waliszewska-Prosół, MD, PhD', 'role': 'CONTACT', 'email': 'marta.waliszewska@gmail.com', 'phone': '(+48) 71 784 12 07'}], 'facility': 'Wrocław Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Isabel Pavão Martins, MD, PhD', 'role': 'CONTACT', 'email': 'ipavaomartins@gmail.com', 'phone': '(+351) 21 780 5000'}], 'facility': 'Hospital Santa Maria Lisbon', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura Dorado, MD, PhD', 'role': 'CONTACT', 'email': 'ldorado.germanstrias@gencat.cat', 'phone': '(+34)93 465 12 00'}], 'facility': 'Germans Trias i Pujol Hospital', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patricia Pozo-Rosich, MD, PhD', 'role': 'CONTACT', 'email': 'cefalea@vhir.org', 'phone': '(+34) 93 489 30 00', 'phoneExt': '2479'}, {'name': 'Edoardo Caronna, MD, PhD', 'role': 'CONTACT', 'email': 'cefalea@vhir.org', 'phone': '(+34) 93 489 30 00', 'phoneExt': '2479'}], 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Albert Muñoz-Vendrell, MD, PhD', 'role': 'CONTACT', 'email': 'amunoz@bellvitgehospital.cat', 'phone': '(+34) 932 60 75 00'}], 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Mollet del Vallès', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Teresa Mateu, MD', 'role': 'CONTACT', 'email': 'teresa.mateu@vhir.org', 'phone': '(+34)934893000', 'phoneExt': '2479'}], 'facility': 'Fundació Sanitària Mollet', 'geoPoint': {'lat': 41.54026, 'lon': 2.21306}}, {'city': 'Viladecans', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mariano Huerta', 'role': 'CONTACT', 'email': 'mhuerta.hv@gencat.cat', 'phone': '(+34) 936 59 01 11'}], 'facility': 'Hospital de Viladecans', 'geoPoint': {'lat': 41.31405, 'lon': 2.01427}}, {'city': 'Albacete', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Almudena Layos-Romero', 'role': 'CONTACT', 'email': 'almudenalayos@gmail.com', 'phone': '(+34) 967 59 71 00'}], 'facility': 'Hospital General Universitario de Albacete', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jaime Rodríguez Vico, MD', 'role': 'CONTACT', 'email': 'jaime.rvico@fjd.es', 'phone': '(+34)915 50 48 00'}], 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alberto Lozano Ros', 'role': 'CONTACT', 'email': 'alozanoros87@gmail.com', 'phone': '(+34) 915 86 80 00'}], 'facility': 'Hospital Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Díaz de Terán, MD, PhD', 'role': 'CONTACT', 'email': 'javierddt@gmail.com', 'phone': '(+34)917277233'}], 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sonia Santos Lasaosa', 'role': 'CONTACT', 'email': 'ssantos@salud.aragon.es', 'phone': '(+34) 976 76 57 00'}], 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Mersin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Aynur Özge', 'role': 'CONTACT', 'email': 'aynurozge@gmail.com', 'phone': '(+90) 324 361 00 01'}], 'facility': 'Mersin University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'Patricia Pozo-Rosich, MD, PhD', 'role': 'CONTACT', 'email': 'cefalea@vhir.org', 'phone': '(+34) 93 489 30 00', 'phoneExt': '2479'}, {'name': 'Edoardo Caronna, MD, PhD', 'role': 'CONTACT', 'email': 'cefalea@vhir.org', 'phone': '(+34) 93 489 30 00', 'phoneExt': '2479'}], 'overallOfficials': [{'name': 'Patricia Pozo-Rosich, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Vall d'Hebron University Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}