zavegepant鼻腔喷雾剂用于偏头痛急性期治疗的长期安全性:2/3 期开放标签研究。

IF 5 2区 医学 Q1 CLINICAL NEUROLOGY
Kathleen Mullin, Robert Croop, Linda Mosher, Terence Fullerton, Jennifer Madonia, Richard B Lipton
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引用次数: 0

摘要

背景:Zavegepant是首个用于鼻内给药急性治疗偏头痛的小分子降钙素基因相关肽受体拮抗剂。本研究旨在评估zavegepant在急性偏头痛治疗中按需重复给药长达一年的安全性和耐受性:这项为期一年的zavegepant 10毫克鼻腔喷雾剂急性治疗偏头痛的2/3期开放标签安全性研究招募了年龄≥18岁、每月有2至8次中度至重度偏头痛发作史的成年人。参与者根据需要使用一剂zavegepant来自我治疗任何严重程度的偏头痛发作,每月最多8次,持续52周:参与者于 2020 年 6 月 29 日至 12 月 4 日期间注册。在进入长期治疗的 608 名参与者中,有 603 人接受了研究药物治疗。参与者平均(标清)每月服用 3.1 (1.55) 次扎韦吉潘。没有死亡病例。在报告的 7 例严重不良事件中,没有一例被认为与治疗有关。共有 6.8%(41/603)的受试者因不良事件而停药。最常见的导致停药的不良事件是消化不良(1.5% [9/603])。最常见的治疗突发不良事件(≥5%的参与者)是消化不良(39.1% [236/603]);鼻部不适(10.3% [62/603]);COVID-19(7.5% [45/603]);恶心(6.1% [37/603]);鼻塞和咽喉刺激(各占5.5% [33/603]);以及背痛(5.3% [32/603])。2.6%[16/603]的受试者出现转氨酶超过正常值上限 3 倍的情况;没有人同时出现胆红素升高超过正常值上限 2 倍的情况:结论:zavegepant 10毫克鼻腔喷雾剂每月使用8次,为期一年,安全性和耐受性良好:试验注册:Clinicaltrials.gov:试验注册:Clinicaltrials.gov:NCT04408794。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study.

Background: Zavegepant is the first small molecule calcitonin gene-related peptide receptor antagonist for intranasal administration for the acute treatment of migraine. The objective of this study was to evaluate the safety and tolerability of zavegepant in the acute treatment of migraine under repeated, as-needed dosing for up to one year.

Methods: This phase 2/3, one-year open-label safety study of zavegepant 10 mg nasal spray for the acute treatment of migraine enrolled adults aged ≥18 years with a history of two to eight moderate to severe monthly migraine attacks. Participants used one dose of zavegepant as needed to self-treat migraine attacks of any severity, up to eight times per month, for 52 weeks.

Results: Participants were enrolled between 29 June and 4 December 2020. Of the 608 participants entering long-term treatment, 603 were treated with study drug. Participants administered a mean (SD) of 3.1 (1.55) zavegepant doses per month. There were no deaths. Of the seven serious adverse events reported, none was considered related to treatment. Altogether, 6.8% (41/603) of treated participants had an adverse event leading to study drug discontinuation. The most frequent adverse event leading to discontinuation was dysgeusia (1.5% [9/603]). The most common treatment-emergent adverse events (≥5% of participants) were dysgeusia (39.1% [236/603]); nasal discomfort (10.3% [62/603]); COVID-19 (7.5% [45/603]); nausea (6.1% [37/603]); nasal congestion and throat irritation (5.5% [33/603] each); and back pain (5.3% [32/603]). Aminotransferases >3x the upper limit of normal occurred in 2.6% [16/603] of participants; none had concurrent elevations in bilirubin >2x upper limit of normal.

Conclusions: One year of zavegepant 10 mg nasal spray up to eight times per month was safe and well tolerated.Trial registration: Clinicaltrials.gov: NCT04408794.

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来源期刊
Cephalalgia
Cephalalgia 医学-临床神经学
CiteScore
10.10
自引率
6.10%
发文量
108
审稿时长
4-8 weeks
期刊介绍: Cephalalgia contains original peer reviewed papers on all aspects of headache. The journal provides an international forum for original research papers, review articles and short communications. Published monthly on behalf of the International Headache Society, Cephalalgia''s rapid review averages 5 ½ weeks from author submission to first decision.
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