Primary Objective:
To evaluate the effectiveness of zavegepant in real-world settings for the acute treatment of migraine. Effectiveness will be evaluated based on the treatment of the first acute migraine attack with zavegepant, in order to capture clinically meaningful treatment response under real-world conditions while minimizing patient burden and missing data. Clinically meaningful treatment response is defined as: An improvement in a patient's condition that is large enough to be perceived as beneficial and to have a tangible impact on how the patient feels and functions.
Secondary Objectives:
To further evaluate the effectiveness of zavegepant for the acute treatment of migraine in real-world settings, including:
* Pain freedom * Absence of the patient-identified most bothersome symptom (MBS) * Absence of individual migraine-associated symptoms (phonophobia, photophobia, and nausea) at 1 hour and 2 hours post dose, among participants with symptoms present at baseline * Sustained pain relief * Return to normal function * Rescue medication use
Exploratory objectives include:
* Evaluation of early treatment response at post-dose timepoints up to 60 minutes * Assessment of consistency of treatment effect across multiple migraine attacks * Time to meaningful pain relief as reported by the participant for the first treated attack
Patient-Reported Outcomes:
Patient-reported outcomes will be collected over a 3-month period to assess the longitudinal patient experience and sustained treatment impact in routine clinical practice.
Participants diagnosed with migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition, beta version
Participants with history of migraine attacks, defined as at least 2 migraine attacks per month during the 3 months prior to screening
Participants that signed the informed consent form
Participants must be 18 years of age or older at the time of consent
Any previous exposure to zavegepant
Females of child-bearing potential who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
Participants who, in the opinion of the investigator, are not suitable for study participation or are unable to comply with study procedures or complete the required one-month follow up, including due to severe visual, auditory, language, cognitive, or consciousness impairments
Participants with history of nasal surgery in the 6 months preceding the screening visit
Single group
Patient Headache Diary
Other interventionPatients will be asked to provide information on the first 2-3 headache attacks during the study
Patient Reported Outcome
Other intervention* Headache Impact Test (HIT-6) to assess the impact of headache on daily functioning and quality of life, collected at screening and V 4 * Migraine Disability Assessment (MIDAS) to evaluate migraine-related disability and functional impairment, collected at screening and V 4 * Patient Global Impression of Improvement (PGI-I) to assess the participants overall perception of treatment benefit, collected V 4 * Work Productivity and Activity Impairment (WPAI: Migraine 2.0) questionnaire to evaluate the effect of migraine on work productivity and daily activities. collected at screening and V 4 * The Patient Health Questionnaire-4 (PHQ-4) is used to assess the presence and severity of both depressive and anxiety symptoms, collected at screening and V 4 * Generalized Anxiety Disorder-7 (GAD-7) to evaluate the presence and severity of anxiety symptoms, collected at screening and V 4 has context menu
intranasal zavegepant
DrugThis intervention is free of charge for the participants of this trial.
Percentage of participants reporting pain relief at 2 hours post-dose following the first use of zavegepant for an acute migraine attack.
Pain relief is defined as a reduction of at least one category in pain intensity from baseline to the specified post-dose timepoint (e.g., severe to moderate, moderate to mild, or mild to none). The primary endpoint will be assessed based on the first treated acute migraine attack.
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