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Multicenter Study
. 2025 Oct 2;26(1):199.
doi: 10.1186/s10194-025-02146-5.

Profiling the real-world migraine patient: public health insights from sociodemographic, lifestyle, and clinical data in the Italian National Migraine Registry (I-GRAINE)

Piero Barbanti  1   2 , Giulia Fiorentini  3   4 , Cecilia Camarda  5 , Massimo Autunno  6 , Francesca Pistoia  7 , Cinzia Aurilia  3 , Florindo d'Onofrio  8 , Gabriella Egeo  3 , Antonio Carnevale  9 , Stefano Caproni  10 , Alberto Doretti  11 , Alessandra Cherchi  12 , Roberto De Simone  13 , Maurizio Zucco  14 , Steno Rinalduzzi  15 , Bruno Colombo  16 , Massimo Filippi  16 , Simone Quintana  17 , Marco Russo  17 , Alfonso Coppola  18 , Rosario Grugno  19 , Marco Bartolini  20 , Giovanna Viticchi  20 , Renata Rao  21   22 , Maria Albanese  23 , Fabrizio Vernieri  24 , Licia Grazzi  25 , Micaela Robotti  26 , Alfonsina Di Summa  27 , Marco Aguggia  28 , Monica Laura Bandettini Di Poggio  29   30 , Cinzia Finocchi  31 , Rossana Terlizzi  32 , Mattia Sansone  33 , Francesca Gragnani  34 , Pietro Querzani  35 , Francesco Perini  36 , Paolo Solla  37 , Valentina Favoni  38 , Ludovica Ferrau  6 , Gennaro Saporito  7 , Elisabetta Iannaccone  8 , Carlo Colosimo  10 , Stefano Messina  11 , Laura Di Clemente  14 , Francesca Cortese  9 , Paola Scatena  15 , Domenico Cosenza  19 , Nicoletta Brunelli  24 , Giacomo Querzola  26 , Annalisa Gai  28 , Sara Cazzulo  29   30 , Francesco Tazza  31 , Martina Guarinoni  39 , Tommaso Ercoli  37 , Sofia Tavani  40 , Bianca Orlando  3 , Francesco Bono  41 , Pietro Antonio Bruno  41 , Stefania Proietti  42 , Stefano Bonassi  43   44 , Carlo Tomino  45 , Annamaria Porreca  43   44 , Paola Torelli  39 , Sabina Cevoli  38 ; Italian Migraine Registry (I-GRAINE) study group
Collaborators, Affiliations
Multicenter Study

Profiling the real-world migraine patient: public health insights from sociodemographic, lifestyle, and clinical data in the Italian National Migraine Registry (I-GRAINE)

Piero Barbanti et al. J Headache Pain. .

Abstract

Background: Although migraine attacks have been precisely characterized over the years - with significant advances in pathophysiology and treatment - the comprehensive identity of the migraine patient remains poorly defined. Real-world data capturing the full sociodemographic and clinical spectrum of individuals with migraine is still limited. The Italian National Migraine Registry (I-GRAINE) was established to address this gap by systematically collecting data on individuals with migraine across Italy's public healthcare system.

Methods: I-GRAINE is an ongoing, nationwide, multicenter, prospective registry involving 43 publicly funded headache centers. Since 19/04/2021, patients diagnosed with episodic migraine (EM) or chronic migraine (CM) have been systematically enrolled. Data were collected through face-to-face interviews conducted by trained neurologists using a dedicated electronic platform. Information included sociodemographic and lifestyle factors, comorbidities, and detailed clinical characteristics. We aimed to define the patient profile, explore the broad clinical phenotype, and compare EM and CM subgroups.

Results: As of 02/05/2025, 1,630 patients had been enrolled (81.7% EM, 18.3% CM), predominantly female (85.4%), mean age 45.7 years, normal BMI (23.2 kg/m2), and high education level. Over 70% were physically inactive, and 32.2% reported sleep disturbances. Headache was typically unilateral (69.1%), pulsating (64.0%), and lasted > 24 h (57.1%). Frequently reported non-ICHD-3 symptoms included osmophobia (41.5%), allodynia (40.5%), dopaminergic symptoms (37.2%), cephalalgiaphobia (34.0%), and dizziness (16.9%). ≥ 1 comorbidity was present in 41.2% of patients. Compared to those with EM, CM patients had higher BMI (24.0 vs. 23.0, p < 0.001), greater sleep disturbances (39.1% vs. 30.6%, p = 0.006), earlier onset (16.5 vs. 17.7 years, p = 0.032), more severe pain (NRS: 8.1 vs. 7.5, p < 0.001), and higher prevalence of medication overuse (58.3% vs. 14.5%, p < 0.001), dopaminergic symptoms (45.1% vs. 35.4%, p = 0.002), allodynia (47.5% vs. 38.9%, p = 0.009), and cephalalgiaphobia (41.4% vs. 32.3%, p = 0.004). Disability was also greater (MIDAS: 76.3 vs. 41.9; HIT-6: 64.3 vs. 61.2; both p < 0.001).

Conclusions: The typical patient attending Italian headache centers is a 45-year-old, normal-weight, well-educated, employed woman, often physically inactive, affected by sleep disturbances, and experiencing an average of 9.8 migraine days/month. I-GRAINE identifies migraine symptoms that may represent endophenotypes and distinct patterns associated with CM, offering valuable real-world insights to inform personalized care, research, and health policy.

Keywords: Chronic migraine; Endophenotype; Episodic migraine; Migraine; Patient registry; Real-world data.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The protocol of the study was approved by the Ethics Committee of the coordinating center, IRCCS San Raffaele Roma (16/int, 31/7/20) and shared by the Ethics Committees of the other centers. Competing interests: Piero Barbanti received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Abbvie, Alder, Allergan, Amgen, Angelini, Assosalute, Bayer, Biohaven, ElectroCore, Eli-Lilly, Fondazione Ricerca e Salute, GSK, Lundbeck, Lusofarmaco, 1MED, MSD, New Penta, Noema Pharma, Novartis, Organon, Orion Pharma, Pfizer, Stx-Med, Teva, Viatris, Visufarma, Zambon and serves as President with Italian Association of Headache Sufferers. Francesca Pistoia received travel grants, honoraria for advisory boards from Allergan/Abbvie, Lilly, Lundbeck, Organon, Pfizer, Novartis, and Teva. Cinzia Aurilia received travel grants from Eli-Lilly, FB-Health, Lusofarmaco and Teva, honoraria from Novartis, Eli-Lilly and Teva. Florindo d’Onofrio received travel grant, honoraria as a speaker or for partecipating in advisory boards from Novartis, Teva, Neopharmed Gentili, Qbgroup srl, K link srl and Eli-Lilly. Gabriella Egeo received travel grants and honoraria from Eli-Lilly, Novartis, New Penta and Ecupharma. Alberto Doretti received compensation for consulting services and/or speaking activities from Abbvie, Eli Lilly, Teva, Lundbeck, Pfizer, IPSEN, Merz, Exeltis, Novartis, Zambon, Neopharmed Gentili, Piam. Bruno Colombo received travel grants honoraria for advisory boards from Lundbeck, Teva, Abbvie, Organon. Massimo Filippi is the Editor-in-Chief of the Journal of Neurology, Associate Editor of Human Brain Mapping, Neurological Sciences, and Radiology; received compensation for consulting services from Alexion, Almirall, Biogen, Horizon, Merck, Novartis, Roche, and Sanofi; speaking activities from Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Horizon, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA; participation in Advisory Boards for Alexion, Biogen, Bristol-Myers Squibb, Horizon, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, and Takeda; scientific direction of educational events for Biogen, Merck, Roche, Celgene, Bristol-Myers Squibb, Lilly, Novartis, and Sanofi-Genzyme; he receives research support from Biogen Idec, Merck-Serono, Novartis, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA). Marco Bartolini received honoraria for speaker activities from Lusofarmaco and Neopharmed. Giovanna Viticchi received honoraria for speaker activities and participating in advisory boards from Eli-Lilly, AbbVie, Teva and Boehringer Ingelheim. Renata Rao received honoraria from Abbvie, Lundbeck, Organon and Pfizer. Fabrizio Vernieri received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Abbvie, Amgen, Angelini, Eli-Lilly, Lundbeck, Organon, Orion Pharma, Pfizer, Novartis, and Teva. Cinzia Finocchi received grants and honoraria from Teva, Abbvie, Organon, Orion, Pfizer, Lundbeck, Lilly. Mattia Sansone received honorarium for speaker activities from Lundbeck. Francesca Gragnani free consultant Lundbeck, Nume Plus, Summeet Srl. Paolo Solla has received speaker honoraria from Alexion, Bayer, Zambon, and Johnson and Johnson. Valentina Favoni received travel grants, honoraria for advisory boards and speaker panels from Abbvie, Eli-Lilly, Lundbeck, Pfizer and Teva. Francesca Cortese received honoraria for advisory board from Abbvie. Francesco Tazza: Orion, Abbvie, Biogen. Paola Torelli received travel grant, honoraria as a speaker, or for participating in advisory boards from Abbvie, Pfizer, Teva, Organon, Lundbeck. Sabina Cevoli received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Abbvie, Angelini, Biohaven, Eli-Lilly, Ipsen, Lundbeck, Novartis, Organon, Pfizer, Teva. Angelo Ranieri Honoraria for speaking activity, consulting, editorial contribution, travel grants from: Lundbeck, TEVA, Ely Lilly, Momento Medico spa, CTP spa, Vyvamed srl, CTP srl, K-link srl, AIM Education srl, Organon, Pfizer. Gennaro Alfieri for editorial contribution, travel grants from: Lundbeck, TEVA, Ely Lilly, Momento Medico spa, Pfizer. Eleonora Colombo received compensation for consulting services and/or speaking activities from Eli Lilly, Lundbeck. Fabio Frediani received honoraria as speaker or for participating in advisory boards from Novartis, Teva and Eli-Lilly. Roberta Messina received honoraria for speaker activities and participating in advisory boards from Abbvie, Biomedia, Eli Lilly, Lundbeck, Pfizer and Teva. Davide Mascarella received educational grant from Organon and travel grant from Teva. Giulia Fiorentini, Marco Aguggia, Maria Albanese, Massimo Autunno, Monica Laura Bandettini di Poggio, Laura Borrello, Stefano Bonassi, Francesco Bono, Nicoletta Brunelli, Pietro Antonio Bruno, Cecilia Camarda, Antonio Carnevale, Stefano Caproni, Sara Cazzulo, Alessandra Cherchi, Carlo Colosimo, Domenico Cosenza, Alfonso Coppola, Laura Di Clemente, Alfonsina Di Summa, Roberto De Simone, Tommaso Ercoli, Ludovica Ferrau, Annalisa Gai, Licia Grazzi, Martina Guarinoni, Rosario Grugno, Elisabetta Iannaccone, Stefano Messina, Francesco Perini, Annamaria Porreca, Stefania Proietti, Simone Quintana, Giacomo Querzola, Pietro Querzani, Steno Rinalduzzi, Micaela Robotti, Marco Russo, Gennaro Saporito, Paola Scatena, Sofia Tavani, Rossana Terlizzi, Carlo Tomino, Maurizio Zucco, Mariamichela Aquino, Vincenzo Andreone, Giulia Bozzo, Ilaria Cetta, Simone Cesarano, Alessandro Cocuzza, Vittoria Carla D'Agostino, Marcella De Luca, Arianna Deidda, Isabella Ferdinanda Pestalozza, Lorenzo Forino, Chiara Gambini, Federica Genovese, Alessandro Gotti, Gabriele Johanna Sixt, Alice Laffranchi, Riccardo Lo Presti, Davide Mantica, Marilena Marcosano, Aurora Masia, Nicola Biagio Mercuri, Enrica Maria Puddu, Prabha Cristina Ranchicchio, Chiara Serafini, Pamela Silva, Giulia Pierangeli, Barbara Petolicchio, Marco Tiriticco, Paolo Vallarino, Gianluca Vita, Laura Zanandrea, Francesco Zoroddu have no disclosures to declare.

Figures

Fig. 1
Fig. 1
Map of the distribution of the 43 Italian Headache centers involved in the I-GRAINE Registry
Fig. 2
Fig. 2
Socio-demographic profile of the most representative patient in the I-GRAINE Registry
Fig. 3
Fig. 3
Migraine accompanying symptoms emerging from the I-GRAINE Registry. On the left, the most common accompanying symptoms, as defined by the diagnostic criteria of the ICHD-3 [12]; on the right, the accompanying symptoms not currently included in the ICHD-3 criteria [12]
See this image and copyright information in PMC

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