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

IF 4.4 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2026-02-01 Epub Date: 2025-12-11 DOI:10.1007/s40122-025-00800-z

Richard B Lipton, Linda Mosher, Robert J Fountaine

{"title":"Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study.","authors":"Richard B Lipton, Linda Mosher, Robert J Fountaine","doi":"10.1007/s40122-025-00800-z","DOIUrl":null,"url":null,"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.","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"325-340"},"PeriodicalIF":4.4000,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12804456/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-025-00800-z","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/12/11 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

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.

Abstract Image

查看原文本刊更多论文

zavegegpant鼻喷雾剂急性治疗偏头痛期间患者报告的结果：来自52周开放标签研究的结果

本研究旨在评估开放标签偏头痛急性治疗zavegepant长达52周期间患者报告结果的变化。方法：数据来自zaveggepant急性治疗偏头痛的2/3期、开放标签、长期安全性研究。偏头痛患者根据需要使用一剂10mg的zavegepent鼻喷雾剂治疗任何强度的偏头痛发作，每天最多一次，每28天最多八次，长达52周。预先指定的探索性终点包括偏头痛天数/月的变化，偏头痛残疾评估（MIDAS）量表的变化，偏头痛特异性生活质量2.1版本（MSQ v2.1）的变化，以及对药物的满意度。结果：共分析了603名治疗参与者。Zavegepant治疗与任何疼痛强度的偏头痛平均减少1.7天/月和中度或重度疼痛强度的偏头痛平均减少1.1天/月相关。zavegpant治疗与第12周平均MIDAS总评分的改善相关，分别为- 8.2 （95% CI - 9.89, - 6.55）和- 8.8 （95% CI - 11.13, - 6.50）。在第12周和第52周，zavegpant治疗分别与MSQ角色功能限制域评分8.6 （95% CI 7.09, 10.16）和13.8 （95% CI 11.76, 15.85）的平均改善相关，角色功能预防域评分6.7 （95% CI 5.25, 8.11）和10.1 （95% CI 8.08, 12.13）的改善相关，情绪功能域评分6.8 （95% CI 4.87, 8.72）和11.3 （95% CI 8.99, 13.70）的改善相关。在第52周，44.2%（125/283）的参与者对zavegepant完全满意或非常满意，28.6%（81/283）的参与者对zavegepant比较满意；124名受试者在第52周未完成用药满意度量表。结论：通过52周的研究，zavegepant急性治疗与平均偏头痛天数/月减少，偏头痛相关残疾和偏头痛特异性生活质量改善以及患者满意度高相关。试验注册：ClinicalTrials.gov标识符NCT04408794。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.