The journal of headache and pain
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Multicenter Study Observational Study
Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study).
Rimegepant, a novel oral calcitonin gene-related peptide receptor antagonist, has been recently approved for the acute migraine treatment. While its efficacy was confirmed in randomized clinical trials, no data is available regarding real-life effectiveness and tolerability. GAINER, a prospective, multicentric study, aimed to evaluate rimegepant effectiveness and tolerability in the real-world setting. ⋯ Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants that includes subjects with episodic or chronic migraine, medication overuse and a high number of prior preventive treatment failures.
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Migraine is a common primary headache disorder, less frequently affecting men than women, and often regarded as predominantly a "women's disease." Despite this, migraine in men presents with unique characteristics in terms of symptoms, treatment responses, comorbidities, and pain perception. Historically, research has focused more on migraine in women, overlooking critical male-specific aspects. ⋯ Men are underrepresented in clinical migraine research. In contrast, preclinical studies often focus solely in male animals as a result of various misconceptions. This disparity necessitates greater focus on sex-specific aspects of migraine to enhance diagnosis, treatment, and research. Addressing stigma, increasing healthcare access, and ensuring balanced sex and gender representation in future studies is crucial for a comprehensive understanding and effective management of migraine for all patients.
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Randomized Controlled Trial
Reduction of pain and functional disability over time in patients treated with zavegepant: a post-hoc analysis of the BHV3500-301 phase 3 randomized controlled trial.
Migraine is a disabling disorder that impacts 40 million people in the US. Zavegepant is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal-spray approved for the acute treatment of migraine with or without aura in adults. This study aimed to evaluate the proportion of patients in various pain and functional disability states over 48-h, for patients treated with zavegepant 10 mg nasal-spray versus placebo. ⋯ This post-hoc analysis demonstrates the benefit of zavegepant nasal spray over placebo on two patient-centric endpoints: time spent with pain freedom and normal functioning over 48-h post-dose. These data support the use of zavegepant for providing rapid and sustained freedom from migraine pain and freedom from migraine related disability, particularly for those who would benefit from the nasal CGRP formulation.
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Part 2 explores the transformative potential of artificial intelligence (AI) in addressing the complexities of headache disorders through innovative approaches, including digital twin models, wearable healthcare technologies and biosensors, and AI-driven drug discovery. Digital twins, as dynamic digital representations of patients, offer opportunities for personalized headache management by integrating diverse datasets such as neuroimaging, multiomics, and wearable sensor data to advance headache research, optimize treatment, and enable virtual trials. In addition, AI-driven wearable devices equipped with next-generation biosensors combined with multi-agent chatbots could enable real-time physiological and biochemical monitoring, diagnosing, facilitating early headache attack forecasting and prevention, disease tracking, and personalized interventions. ⋯ Despite these advances, challenges such as data standardization, model explainability, and ethical considerations remain pivotal. Collaborative efforts between clinicians, biomedical and biotechnological engineers, AI scientists, legal representatives and bioethics experts are essential to overcoming these barriers and unlocking AI's full potential in transforming headache research and healthcare. This is a call to action in proposing novel frameworks for integrating AI-based technologies into headache care.