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Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week,

Richard B Lipton¹, Linda Mosher², Robert J Fountaine³

¹Department of Neurology and Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.

Pain and Therapy

|December 11, 2025

Abstract

Introduction:

This study aimed to assess changes in patient-reported outcomes during open-label acute treatment of migraine with zavegepant for up to 52 weeks.

Methods:

Data were from a phase 2/3, open-label, long-term safety study of zavegepant for the acute treatment of migraine. Participants with migraine treated migraine attacks of any intensity as needed with one dose of zavegepant 10 mg nasal spray, up to once per day and up to eight times per 28 days, for up to 52 weeks. Pre-specified exploratory endpoints included change in number of migraine days/month, change in Migraine Disability Assessment (MIDAS) Scale, change in Migraine-Specific Quality of Life version 2.1 (MSQ v2.1), and Satisfaction with Medication.

Results:

A total of 603 treated participants were analyzed. Zavegepant treatment was associated with mean reductions of 1.7 migraine days/month of any pain intensity and 1.1 migraine days/month of moderate or severe pain intensity. Zavegepant treatment was associated with improvement in mean MIDAS total score of - 8.2 (95% CI - 9.89, - 6.55) at week 12 and - 8.8 (95% CI - 11.13, - 6.50) at week 52. At week 12 and week 52, respectively, zavegepant treatment was associated with improvements in mean MSQ Role Function Restrictive domain score of 8.6 (95% CI 7.09, 10.16) and 13.8 (95% CI 11.76, 15.85), improvement in Role Function Preventive domain score of 6.7 (95% CI 5.25, 8.11) and 10.1 (95% CI 8.08, 12.13), and improvement in Emotional Function domain score of 6.8 (95% CI 4.87, 8.72) and 11.3 (95% CI 8.99, 13.70). At week 52, 44.2% (125/283) of participants were completely or very satisfied with zavegepant and 28.6% (81/283) were somewhat satisfied; 124 participants did not complete the Satisfaction with Medication scale at week 52.

Conclusion:

Through the 52-week study, acute treatment with zavegepant was associated with reduction in mean number of migraine days/month, improvements in migraine-related disability and migraine-specific quality of life, and high levels of patient satisfaction.

Trial Registration:

ClinicalTrials.gov identifier NCT04408794.

Keywords:

Disability Episodic migraine Patient-reported outcome measures Quality of life Zavegepant

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