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

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.