BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm,Cephalalgia

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BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm
Cephalalgia ( IF 4.9 ) Pub Date : 2021-08-18 , DOI: 10.1177/03331024211034508
Daniele Martinelli _{1,

2} , Sebastiano Arceri _{1,

2} , Roberto De Icco _{1,

2} , Marta Allena ₂ , Elena Guaschino ₂ , Natascia Ghiotto ₂ , Vito Bitetto ₂ , Gloria Castellazzi _{2,

3,

4} , Giuseppe Cosentino _{1,

2} , Grazia Sances ₂ , Cristina Tassorelli _{1,

2}

Affiliation

Abstract

Introduction

In this open label, single-arm trial we evaluated the efficacy of onabotulinum toxin-A in the prevention of high-frequency episodic migraine (8–14 migraine days/month).

Methods

We enrolled 32 high-frequency episodic migraine subjects (age 44.8 ± 11.9 years, 11.0 ± 2.2 migraine days, 11.5 ± 2.1 headache days, 7 females). After a 28-day baseline period, subjects underwent 4 subsequent onabotulinum toxin-A treatments according to the phase III research evaluating migraine prophylaxis therapy (PREEMPT) paradigm, 12-weeks apart. The primary outcome was the reduction of monthly migraine days from baseline in the 12-week period following the last onabotulinum toxin-A treatment

Results

Onabotulinum toxin-A reduced monthly migraine days by 3.68 days (−33.1%, p < 0.01). Thirty-nine percent of the patients experienced a ≥50% reduction in monthly migraine days. Onabotulinum toxin-A also reduced the number of headache days (−33.9%, p < 0.01) and the intake of acute medications (−22.9%, p = 0.03). Disability and quality of life (QoL) scores improved markedly (migraine disability assessment (MIDAS) −41.7%; migraine specific questionnaire (MSQ) −31.7%, p < 0.01).

Conclusions

The findings suggest that, when administered according to the PREEMPT paradigm, onabotulinum toxin-A is effective in the prevention of high-frequency episodic migraine.

Trial Registration: NCT04578782

中文翻译：

BoNT-A 在高频偏头痛中的疗效：应用 PREEMPT 范式的开放标签、单臂、探索性研究

摘要

介绍

在这项开放标签的单臂试验中，我们评估了肉毒杆菌毒素 A 在预防高频发作性偏头痛（8-14 天/月偏头痛）方面的功效。

方法

我们招募了 32 名高频发作性偏头痛受试者（年龄 44.8 ± 11.9 岁，11.0 ± 2.2 偏头痛天数，11.5 ± 2.1 头痛天数，7 名女性）。在 28 天的基线期后，根据评估偏头痛预防治疗 (PREEMPT) 范式的 III 期研究，受试者接受了 4 次后续的肉毒杆菌毒素 A 治疗，间隔 12 周。主要结果是在最后一次肉毒杆菌毒素 A 治疗后的 12 周内，每月偏头痛天数比基线减少

结果

Onabotulinum toxin-A 使每月偏头痛天数减少了 3.68 天（-33.1%，p < 0.01）。39% 的患者每月偏头痛天数减少 ≥ 50%。Onabotulinum toxin-A 还减少了头痛天数 (-33.9%, p < 0.01) 和急性药物的摄入量 (-22.9%, p = 0.03)。残疾和生活质量 (QoL) 得分显着提高（偏头痛残疾评估 (MIDAS) -41.7%；偏头痛特定问卷 (MSQ) -31.7%，p < 0.01）。