The main objective is to assess the feasibility of treatment by injecting botulinum toxin A into the hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A is carried out at the end of a single session during an hospitalization. Furthermore, tolerance and effects on the disease are evaluated at 1, 3 and 6 months post injections.

开始日期2025-01-01

申办/合作机构

Toulouse University Hospital

NCT06237465 / Not yet recruiting临床4期IIT

Botulinum Toxin-A for Hidradenitis Suppurativa

The purpose of this research study is to determine if the medication Botulinum Toxin-A (BTX-A) is effective in treating hidradenitis suppurativa (HS)

开始日期2025-01-01

申办/合作机构

Yale University

NCT05910983 / Not yet recruitingN/AIIT

Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial

The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).

开始日期2025-01-01

申办/合作机构

Menoufia University

100 项与 A型肉毒毒素相关的临床结果

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100 项与 A型肉毒毒素相关的转化医学

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100 项与 A型肉毒毒素相关的专利（医药）

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2,374

项与 A型肉毒毒素相关的文献（医药）

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

A multicenter, double-blind, randomized, parallel-group, active-controlled, phase 3 clinical trial to compare the effectiveness and safety of two botulinum toxin type A formulations for improving moderate to severe glabellar wrinkles in Asians

Article

作者: Koh, Young Gue ; Won, Chonghyun ; Yoon, Yi Na ; Kim, Eun-Kyoung ; Choi, Sun Young ; Lee, Yang Won ; Son, Joo-Sun ; Cho, Hyesoo ; Kim, Beom Joon ; Son, Hyung Seok ; Kim, Gyeonghoon

Botulinum toxin type A (BoNT-A) was first isolated in 1946, and since then, several formulations have been developed and widely used to treat wrinkles by inducing muscle paralysis. This multicenter, double-blind, randomized, parallel-group, active-controlled phase 3 clinical trial was designed to evaluate the efficacy and safety of a newly developed BoNT-A formulation, BMI2006, in improving moderate to severe glabellar wrinkles and to compare with existing onabotulinumtoxin A (OBoNT) injections. A total of 276 subjects were enrolled and received 20 units of the randomized material, which was intramuscularly injected into five different locations on the forehead. The primary endpoint, assessed at 4 weeks, showed no statistically significant difference in the improvement rate of glabellar wrinkles between the two groups, with BMI2006 demonstrating non-inferiority to comparator BoNT-A. Secondary endpoints, evaluated by both treating investigators and independent investigators, also exhibited similar improvement rates throughout the study period. Both groups reported high levels of satisfaction with no statistical difference between the two groups. Safety evaluations indicated mild and transient adverse events, with no serious reactions observed. In conclusion, BMI2006 is an effective and safe BoNT-A for treating glabellar wrinkles with an expected duration of action between 8 and 12 weeks.

2024-11-30·FASEB JOURNAL

Muscle type‐specific effects of bilateral abobotulinumtoxinA injection on muscle growth and contractile function in spastic mice

Article

作者: Noort, Wendy ; Jaspers, Richard T. ; Kalinichev, Mikhail ; Wüst, Rob C. I. ; Loos, Maarten ; Koopmans, Bastijn ; Vignaud, Alban ; Rivares, Cintia ; Baan, Guus

Abstract:

Intramuscular injection of botulinum neurotoxin type A (BoNT‐A) is commonly used to improve or maintain the joint range of motion in young children with spasticity. However, the effectiveness of BoNT‐A treatment is variable and movement limitations are recurrent. Here we show long‐term effects of a single, bilateral abobotulinumtoxinA (aboBoNT‐A) injection in the gastrocnemius medialis and soleus muscles of wild‐type and spastic (B6.Cg‐Glrbspa/J with a mutation in the glycine receptor) mice at a young age (6–7 days). Specifically, we evaluated the impact of aboBoNT‐A‐A on gait, physical performance, and spontaneous physical behavior, as well as on contractile force characteristics, morphology, and histological phenotype of soleus and gastrocnemius muscles by comparing their results to those of saline‐injected controls up to 9 weeks after the injection. The detailed time course of the study specifies the timing of the aboBoNT‐A injection at 1 week, the period of behavioral studies from 4–9 weeks, and the age of the mice (10 weeks) at the time of contractile force characteristics and histology assessments. In spastic mice, aboBoNT‐A injection had a minor and very specific effect on physical performance, by only modestly increasing stride length as a function of age. aboBoNT‐A injection caused a reduction in the force‐generating capacity and a slightly smaller physiological cross‐sectional area in gastrocnemius medialis, but not in soleus. Reduced physiological cross‐sectional area in aboBoNT‐A‐injected muscles was due to a lower number of muscle fibers, rather than reduced muscle fiber cross‐sectional area. The percentage of slow‐type muscle fibers and mitochondrial succinate dehydrogenase activity were increased, which was associated with an improved muscle endurance capacity. In conclusion, aboBoNT‐A injection reduced the number of muscle fibers, causing muscle hypertrophy in remaining fibers and a shift towards more oxidative fibers, resulting in an improved endurance capacity and gait. This study proposed potential cellular mechanisms for the therapeutic efficacy of aboBoNT‐A in spasticity.

2024-11-01·Journal of voice : official journal of the Voice Foundation

Cricothyroid Muscle Botulinum Toxin Chemodenervation to Treat Recalcitrant High-Pitched Functional Dysphonia in an Adult Male

Article

作者: Johns, Michael M ; van der Woerd, Benjamin ; Sund, Lauren Timmons ; Ziltzer, Ryan S

INTRODUCTION:

Functional dysphonia occurs in the absence of structural or neurologic laryngeal abnormalities with various manifestations including aphonia and inappropriate vocal pitch. Voice therapy is the first-line treatment, and literature on treatment options for functional dysphonia unresponsive to voice therapy is limited.

METHODS:

Retrospective medical records review and report of a case.

RESULTS:

We report a unique case of an adult male with recalcitrant high-pitched functional dysphonia of adult-onset that was successfully treated with a single cricothyroid muscle botulinum toxin (Botox) chemodenervation injection.

CONCLUSION:

Cricothyroid muscle botulinum toxin chemodenervation can be an effective treatment for recalcitrant functional dysphonia.

300

项与 A型肉毒毒素相关的新闻（医药）

2024-12-03

·PRNewswire

ShiraTronics Initiates IDE Pivotal Study of Implantable Neuromodulation Therapy for Chronic Migraine

First Implants of Innovative Device Completed in the United States and Australia MINNEAPOLIS, Dec. 3, 2024 /PRNewswire/ -- ShiraTronics, a clinical-stage innovator in neuromodulation technology, today announced the initiation of its U.S. Food and Drug Administration (FDA)-approved Investigation Device Exemption (IDE) pivotal trial, the RELIEV-CM2 Clinical Study. The first implants of ShiraTronics neuromodulation therapy for Chronic Migraine have been completed in the United States and Australia, marking a new chapter in the company's efforts to develop innovative solutions for individuals impacted by this disabling condition. Continue Reading ShiraTronics device (PRNewsfoto/ShiraTronics, Inc.) The RELIEV-CM2 Clinical Study will implant up to 148 patients across the United States and Australia to assess the long-term safety and potential efficacy of ShiraTronics implantable neuromodulation therapy. Unlike other approaches that primarily manage migraine symptoms, the ShiraTronics System is designed to provide preventive, sustained relief for those who experience 15 or more headache days per month and have not achieved success with other treatments. For many of the millions who live with the challenging effects of Chronic Migraine, this novel approach could represent a potential new therapy option. Dr. Sandeep Vaid was the first physician to implant the ShiraTronics System in the United States. "Bringing this new therapy to patients represents an exciting step forward in migraine management. Chronic Migraine has a profound impact on people's lives, limiting daily activities and affecting overall well-being. This device offers a fresh approach that, based on early results, holds promise for improving how patients function day-to-day. It's a privilege to be part of this pivotal study and witness what this technology might mean for patients who have exhausted other options," said Dr. Vaid. Dr. Vaid is Board Certified in Pain Management, Neurology, and Brain Injury Medicine and serves as Medical Director of Clinical Research at Vista Clinical Research in Newnan, Georgia. Rising Demand for Long-Term Solutions for Chronic Migraine Migraine affects nearly 2% of the global population and is often marked by severe, pulsating headaches, sensory sensitivity, nausea, and fatigue. Patients with Chronic Migraine, a more severe form of migraine, experience headaches 15 or more days per month, with at least eight days accompanied by intense and disabling migraine symptoms. Despite available treatments—such as prescription pills, CGRP inhibitors, and Botox injections—millions of patients in the United States are unable to control the disease with current preventive treatment options and therefore continue to struggle with symptoms that significantly impact their quality of life, physical and emotional well-being, and productivity. This has highlighted an urgent need for alternative therapies that could provide more consistent and lasting relief. The ShiraTronics System was designed with this need in mind. By delivering targeted electrical impulses to key nerve pathways, the device is placed just beneath the skin and aims to relieve, interrupt and prevent migraine frequency and severity, potentially providing a new, non-pharmacologic option for those seeking a solution to Chronic Migraine's disabling effects. Limitations of Current Chronic Migraine Treatments Current migraine treatments primarily focus on managing symptoms, and some can lead to dependency, rebound headaches, or difficult side effects. Preventive options often require regular healthcare visits for injections, or repeatedly self-administering injections, which can disrupt patients' lives. Often patients find that these treatments fail to deliver adequate relief or result in side effects that hinder quality of life, making them challenging to continue. The ShiraTronics System aims to address these limitations by targeting the nerve pathways involved in Chronic Migraine with precise, 24/7 electrical neuromodulation. The goal is to provide an approach that can potentially reduce the frequency and intensity of migraine attacks, allowing patients to maintain their daily activities with fewer disruptions and less dependence on continuous medication or invasive treatments. Early Pilot Study Success The RELIEV-CM Pilot Study, an earlier study by ShiraTronics, provided encouraging initial insights. Among a cohort of 10 Chronic Migraine patients who had not responded to conventional treatments, 80% reported a 50% reduction in migraine frequency after three months, with some experiencing reduced severity as well. Additionally, 60% of participants reported decreased reliance on acute medications, with several discontinuing them within the first six months of therapy. "The minimally invasive nature of this procedure allows us to implant the device efficiently, making the procedure easily adopted by implanting physicians. The initial results we've seen have been very promising, and the procedure itself has been both straightforward and well-received by patients. I'm honored to contribute to the development of a therapy that could offer sustainable benefits for those living with persistent, treatment-resistant migraines," said Associate Professor Marc Russo, an internationally recognized leader in neuromodulation and Immediate Past-President of the International Neuromodulation Society (INS). Associate Professor Russo also serves as Director at Large of the Neuromodulation Society of Australia and New Zealand (NSANZ). Looking Ahead: Moving Migraine Research Forward As the RELIEV-CM2 Clinical Study progresses, ShiraTronics is collaborating closely with healthcare professionals and patients to evaluate the long-term safety and potential of its neuromodulation therapy. The company is focused on advancing this technology aiming to improve patient outcomes, with the intention of making this innovative approach widely available to Chronic Migraine patients in the future. While still in the early stages, the study underscores the potential impact of the ShiraTronics System for those who have exhausted traditional treatment options. "Our mission is to provide a new therapy option for chronic migraine patients that will reduce the impact of migraine, restore functionality and improve quality of life," said Fred Ecklund, VP Global Clinical Affairs. About ShiraTronics ShiraTronics, a Minneapolis-based, privately-held medical device innovator, is at the forefront of neuromodulation solutions to transform the lives of those suffering from Chronic Migraine. The ShiraTronics Migraine Therapy System is a groundbreaking technology designed to deliver continuous, targeted neurostimulation, aiming to relieve, interrupt, and prevent migraine attacks. With this state-of-the-art system, ShiraTronics is committed to advancing migraine treatment and improving the quality of life for those affected by this challenging condition. For more information about ShiraTronics and the RELIEV-CM2 Clinical Study, please visit shiratronics.com. SOURCE ShiraTronics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-12-02

·复星医药

复星医药许可引进的专利肽类长效A型肉毒毒素达希斐®颈部肌张力障碍适应症获在中国获批

复星医药（600196.SH；02196.HK）宣布，获许可产品注射用A型肉毒毒素（中国境内商标：达希斐®、英文商标：DAXXIFY®，项目代号：RT002，以下简称“该产品”）的成人颈部肌张力障碍（Cervical Dystonia，简称CD）适应症注册申请近日已获国家药品监督管理局（“国家药监局”）批准，这是达希斐®在中国内地获批的第二个适应症。达希斐®的专利配方含有纯150kd核心神经毒素和专利肽辅料RTP004，不含动物蛋白或其他辅助蛋白。复星医药控股子公司上海复星医药产业发展有限公司（“复星医药产业”）于2018年12月获美国Revance Therapeutics, Inc.许可于区域内（即中国内地、香港及澳门特别行政区）独家进口、使用、开发及商业化（不包括制造）该产品。该产品为DaxibotulinumtoxinA-lanm，拟用于美容适应症，暂时性改善成人因皱眉肌和/或降眉间肌活动引起的中度至重度眉间纹；以及治疗适应症，治疗成人颈部肌张力障碍。 2024年9月，达希斐®美容适应症获国家药品监督管理局（“国家药监局”）批准，用于暂时性改善成人因皱眉肌和/或降眉间肌活动引起的中度至重度眉间纹，作为20多年来同类产品的首次创新，达希斐®采用其专有的肽交换技术（Peptide Exchange Technology，PXT）开发的含有稳定肽制剂和高度纯化的A型肉毒毒素的新一代神经调节剂，为广大患者提供卓越的疗效。 01 颈部肌张力障碍患者疗程间隔期内症状复发非常普遍颈部肌张力障碍（Cervical dystonia，CD）是一种慢性神经系统疾病，是临床最常见的局灶性肌张力障碍疾病之一。其特征是颈部肌肉的自发性不自主收缩，导致头部、颈部和肩部的异常运动或姿势改变1。国内外指南共识均推荐“A型肉毒毒素”作为CD的一线治疗选择2,3。目前全球范围内已有多款肉毒毒素制剂上市，出于多次重复注射引起免疫原性的担心，目前肉毒毒素制剂产品的注射疗程一般建议至少间隔3个月（12周）4，但CD患者疗程间隔期内症状复发较为普遍，复发平均时间约为10.5周，在每个疗程末期满意程度较低，是CD患者的常见问题5。 02 中位疗效持续时间达24周，达希斐®持久改善患者症状达希斐®于2023年8月14日获得美国FDA批准，用于治疗颈部肌张力障碍6，其治疗CD的III期临床研究（ASPEN-1）于今年2月发表在《Journal of Neurology》杂志上7。全球III期和中国III期临床研究（ASPEN-CN）的汇总研究以摘要形式在今年运动障碍协会（MDS）年会上发表8。研究结果证实了达希斐®在中度至重度原发性颈部肌张力障碍成人中的疗效和安全性，中位疗效持续时间可达24周，与其在眉间纹的III期临床研究和上肢痉挛的II期研究结果中表现出的“长效”特征一致，中位疗效持续为24~28周9–11。达希斐®作为全球首款专利肽类长效A型肉毒毒素制剂，有望解决CD患者治疗中疗程间期内症状复发普遍这一未满足需求，进一步提高患者生活质量，减少每年的治疗次数。 ASPEN-1是一项国际多中心、随机、双盲、安慰剂对照研究7（clinicaltrials注册号：NCT03608397），共招募患者301人。ASPEN-1-CN在中国进行，研究设计与ASPEN-1相同。ASPEN-1和ASPEN-CN汇总分析共纳入患者357人8，其中含中国III期患者56人，占分析人群的15.7%。汇总分析结果显示，与安慰剂相比，第4周和第6周多伦多西方痉挛性斜颈评分量表（TWSTRS）总分较基线的变化均值（DAXI 125U组为-12.0，DAXI 250U组为-11.9）均有统计学差异（p<0.0001），两种剂量均能显著降低TWSTRS总分，改善患者症状。中位疗效持续时间（定义为从开始治疗到TWSTRS总分改善疗效损失到最小剩余益处（“minimum residual benefit”，即TWSTRS总评分改善的峰值治疗效果损失超过80 %）的时间）（95%CI）分别为：达希斐® 250U：22.0(20.1，24.3)周；达希斐® 125U：24.1（20.6，28.9）周（见图1）。安全性方面，大多数治疗中出现的不良事件（TEAE）为轻度或中度。治疗组中吞咽困难发生率4.5-4.7%，肌无力发生率4.5-5.4%，低于既往获批的用于CD治疗的其他A型肉毒毒素产品的关键临床研究数据4,12,13。图1. 达希斐®用于治疗CD的TWSTRS总分与基线相比随时间的变化 03 达希斐®未来可期多位专家对达希斐®获批CD适应证表示热烈祝贺，并对其在我国肉毒毒素疾病治疗领域中的应用前景寄予厚望。万新华教授北京协和医院，中国神经科学学会神经毒素分会名誉主任委员，达希斐®中国III期临床研究（ASPEN-1-CN）主要研究单位PI “ III期临床研究证实了达希斐®的疗效和安全性，尤其持续时间能达到24周是非常不错的结果。事实上，肉毒毒素有着非常广泛的疾病治疗应用前景，如肌张力障碍、自主神经系统疾病、神经病理性疼痛等。期待这款新的A型肉毒毒素的获批，可以造福中国更多患者。 ” 靳令经教授同济大学附属养志康复医院，中国神经科学学会神经毒素分会主任委员，达希斐®中国III期临床研究（ASPEN-1-CN）参与研究单位PI “ 达希斐®获批CD适应证为CD患者带来更多治疗选择。达希斐®中位疗效持续时间达24周、持久改善患者症状，对于改善患者长期治疗的依从性，进一步提高患者生活治疗很有意义。同时，其制剂组成“不含动物蛋白，不含辅助蛋白，只含核心神经毒素和专利肽赋形剂RTP004”，为“继发性无应答”的患者带来全新的治疗选择。 ” 参考资料 1. Stacy M. Epidemiology , clinical presentation , and diagnosis of cervical dystonia. Neurologic Clinics. 2008;26:23-42. doi:10.1016/S0733-8619(08)80003-5 2. Albanese A, Abbruzzese G, Dressler D, et al. Practical guidance for CD management involving treatment of botulinum toxin: a consensus statement. J Neurol. 2015;262(10):2201-2213. doi:10.1007/s00415-015-7703-x 3. 中华医学会神经病学分会帕金森病及运动障碍学组,中华医学会神经外科学分会功能神经外科学组,中国神经科学学会神经毒素分会,等. 肌张力障碍治疗中国专家共识[J]. 中华神经科杂志,2020,53(11):868-874. DOI:10.3760/cma.j.cn113694-20200531-00404. 4. Allergan. BOTOX® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use prescribing information. Accessed Nov 23, 2023. rxabbvie. com/pdf/botox_pi.pdf. 5. Comella C, Ferreira JJ, Pain E, Azoulai M, Om S. Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia. J Neurol. 2021;268(3):903-912. doi:10.1007/s00415-020-10217-7 6. U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia. Accessed October 25, 2023. https://investors.revance.com/investors/Press-Releases/news-details/2023/U.S.-FDA-Approves-First-Therapeutic-Indication-for-Revances-DAXXIFY-DaxibotulinumtoxinA-lanm-for-Injection-for-the-Treatment-of-Cervical-Dystonia/default.aspx 7. Comella CL, Jankovic J, Hauser RA, et al. Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial. Neurology. 2024;102(4):e208091. doi:10.1212/WNL.0000000000208091 8. D. Truong, H. Xingyue, A. Ellenbogen, J. Lingjing, K. Dashtipour, A. Patel, T. Gross, R. Kazerooni, C. Gallagher, F. Xiaojin, S. Yunan, G. Lei, W. Xinhua, D. Hollander. Efficacy and Safety of DaxibotulinumtoxinA-lanm for Injection in Adults with Cervical Dystonia: Pooled Global Analysis of ASPEN-1 and ASPEN-1-CN [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-daxibotulinumtoxina-lanm-for-injection-in-adults-with-cervical-dystonia-pooled-global-analysis-of-aspen-1-and-aspen-1-cn/. Accessed November 18, 2024. 9. Carruthers JD, Fagien S, Joseph JH, et al. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plastic & Reconstructive Surgery. 2020;145(1):45-58. doi:10.1097/PRS.0000000000006327 10. Bertucci V, Solish N, Kaufman-Janette J, et al. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). Journal of the American Academy of Dermatology. 2020;82(4):838-845. doi:10.1016/j.jaad.2019.06.1313 11. Revance to Present Data from Phase 2 JUNIPER Clinical Trial Evaluating DAXXIFYTM (DaxibotulinumtoxinA-lanm) Injection for the Treatment of Upper Limb Spasticity at the International Congress of Parkinson and Movement Disorder Society (MDS). September 15, 2022. Accessed February 19, 2024. https://www.businesswire.com/news/home/20220915005412/en/Revance-to-Present-Data-from-Phase-2-JUNIPER-Clinical-Trial-Evaluating-DAXXIFY%E2%84%A2-DaxibotulinumtoxinA-lanm-Injection-for-the-Treatment-of-Upper-Limb-Spasticity-at-the-International-Congress-of-Parkinson-and-Movement-Disorder-Society-MDS 12. Ipsen. DYSPORT (abobotulinumtoxinA) for injection, for intramuscular use prescribing information. Accessed Nov 23, 2024. ipsen.com/websites/Ipsen_Online/wp-content/ uploads/sites/9/2019/01/21084019/Dysport_Full_Prescribing_Information.pdf. 13. XEOMIN-Full-Prescribing-Information-including-MedGuide.pdf. Accessed Nov 23, 2024. https://www.xeominaesthetic.com/wp-content/uploads/2019/05/XEOMIN-Full-Prescribing-Information-including-MedGuide.pdf P-20241121-014 仅供医疗卫生人士参考

临床3期

2024-11-27

·Insight数据库

用于颈部肌张力障碍，复星医药 A 型肉毒杆菌毒素获批新适应症

11 月 27 日，NMPA 官网显示，复星医药注射用 A 型肉毒毒素（Daxxify）的新适应症获得批准，用于治疗颈部肌张力障碍（受理号：JXSS2300053）。截图来源：NMPA 官网 Daxxify 是基于 Revance Therapeutics 专有的 TransMTs 技术平台开发出的含有稳定肽制剂和高度纯化的 A 型肉毒杆菌毒素的新一代神经调节剂，是首款也是唯一一款长效肽制剂神经调节剂，其不含人血清白蛋白和动物成分，可以在无需冷藏的条件下保持两年稳定性。 2018 年 12 月，复星医药与 Revance Therapeutics 就该产品达成合作许可协议。据协议，复星医药以 8800 万美元以获得其在中国大陆、香港、澳门地区商业化的权利。目前，Daxxify 已在美国获批两项适应症：改善成人中重度皱眉纹（眉间纹）（2022.09）；颈部肌张力障碍（2023.08）。在国内，该产品于 2024 年 9 月被 NMPA 批准用于暂时性改善成人因皱眉肌/或降眉间肌活动引起的中度至重度皱眉纹。 Daxxify 获批治疗颈部肌张力障碍是基于 III 期临床研发项目的研究结果，包括多中心、双盲、安慰剂对照研究 ASPEN-1 和开放标签阶段 ASPEN-OLS。其中《Journal of Neurology》杂志上发表的 ASPEN-1 研究结果显示：与安慰剂组相比，Daxxify 125U 和 250U 治疗组均表现出良好的效力。且 Daxxify 起效快，在首次随访时（第 2 周）就可观察到治疗效应。具体数据为：主要疗效终点上，Daxxify 125U 和 250U 治疗组多伦多西方痉挛性斜颈评分量表（TWSTRS）总分在第 4 周和第 6 周的平均值较基线的变化分别为-12.7(1.30) 和-10.9(1.25)。关键次要疗效终点上，Daxxify 125U 和 250U 治疗组临床总体印象变化 (CGIC) 应答率 95% 的患者比例分别为 60.8 % 、56.9%，而安慰剂组为 28.3 % 。Daxxify 125U 和 250U 治疗组患者总体印象变化 ( PGIC ) 应答率 95% 的患者比例分别为 53.6%、50.8%，而安慰剂组为 21.7%。 Daxxify 125U 和 250U 治疗组的中位疗效持续时间分别为 24.0 和 20.3 周。安全性方面，大多数 TEAEs 都是轻到中度，没有治疗相关的严重 TEAE。最常见的与 Daxxify 治疗相关的 TEAEs 为注射部位疼痛、头痛和注射部位红斑。常见的治疗相关 TEAEs 为肌无力、肌肉骨骼疼痛、吞咽困难。其中 Daxxify 治疗患者吞咽困难的发生率明显低于其他上市的肉毒毒素产品。据悉，Daxxify 治疗孤立性颈部肌张力障碍的国际 III 期临床研究的中国扩展研究（ASPEN-1-CN）已完成，其在国内获批将为颈部肌张力障碍患者提供一种新选择。颈部肌张力障碍（CD）是一种慢性神经系统疾病，是临床最常见局灶性肌张力障碍疾病，特征是颈部肌肉的自发性不自主收缩，导致头部、颈部和肩部的异常运动或姿势改变。国内外指南共识均推荐「A 型肉毒毒素」作为 CD 一线治疗。Daxxify 的获批将为 CD 提供一种新选择。封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期临床结果上市批准临床成功临床2期

100 项与 A型肉毒毒素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08957	A型肉毒毒素	M03AX01	DB00083

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
咀嚼肌肥大	中国	Allergan, Inc.	2024-06-03
肌张力失调	美国	AbbVie, Inc.	2022-08-22
神经源性逼尿肌过度活动	美国	AbbVie, Inc.	2022-08-22
尿失禁	美国	AbbVie, Inc.	2022-08-22
发声困难	日本	GSK Plc	2018-05-25
额头皱纹	美国	AbbVie, Inc.	2017-10-02
膀胱功能障碍	美国	AbbVie, Inc.	2017-04-04
外眦皱纹	美国	AbbVie, Inc.	2013-09-11
上下肢痉挛	美国	AbbVie, Inc.	2010-03-09
马蹄状畸形	日本	Allergan, Inc.	2009-01-21
多汗症	日本	Allergan, Inc.	2009-01-21
偏头痛	日本	-	2009-01-21
皮肤疾病	日本	Allergan, Inc.	2009-01-21
神经性膀胱功能障碍	日本	Allergan, Inc.	2009-01-21
膀胱过度活动症	日本	Allergan, Inc.	2009-01-21
原发性颈性肌张力障碍	日本	GSK Plc	2005-10-03
肌肉痉挛	-	Genesis Healthcare, Inc.	2005-10-03
原发性腋窝多汗症	美国	AbbVie, Inc.	2004-07-19
斜视	美国	AbbVie, Inc.	2004-07-19
眼睑痉挛	中国	Allergan Pharmaceuticals Ireland ULC	2003-04-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
颈阔肌突出	临床3期	美国	AbbVie, Inc.	2021-07-08
颈阔肌突出	临床3期	加拿大	AbbVie, Inc.	2021-07-08
肌张力障碍	临床3期	加拿大	Allergan Ltd. (Ireland)	2021-01-12
疼痛	临床3期	加拿大	Allergan Ltd. (Ireland)	2021-01-12
帕金森病	临床3期	加拿大	Allergan Ltd. (Ireland)	2021-01-12
鱼尾纹	临床3期	日本	Allergan Ltd. (Ireland)	2013-01-31
头痛	临床3期	美国	Allergan Ltd. (Ireland)	2012-10-01
脑瘫	临床3期	西班牙	Allergan Ltd. (Ireland)	2011-11-01
流涎	临床3期	西班牙	Allergan Ltd. (Ireland)	2011-11-01
轻瘫	临床3期	美国	Allergan Ltd. (Ireland)	2010-04-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06080438 (CTgov)	临床4期	多泪 \| 眼睑痉挛	2	Botulinum toxin	憲餘衊艱艱選鹽顧簾繭(餘糧築積鹽膚網鬱淵淵) = 鬱製願窪願構遞糧獵鹹繭繭齋齋構艱廠衊艱顧 (遞膚繭衊鬱鬱鹽膚糧鑰, 構廠鑰壓襯築範製鹽糧 ~ 願夢遞餘獵顧壓廠齋廠) 更多	-	2024-12-05
NCT05134649 (CTgov)	临床3期	颈阔肌突出	292	OnabotulinumtoxinA	窪顧選艱窪鏇夢願鬱糧(蓋蓋願遞蓋鹽窪膚蓋膚) = 衊鹹淵餘夢製簾獵淵選衊顧壓積鑰廠夢獵製膚 (窪構遞鑰鏇鏇膚衊範醖, 齋築遞製鑰襯鹹製艱遞 ~ 餘顧膚築壓齋獵膚構夢) 更多	-	2024-12-05
NCT04949399 (CTgov)	临床3期	颈阔肌突出	408	Placebo (Placebo)	夢範壓鹹蓋簾膚夢壓蓋(蓋襯選製壓夢觸觸鬱範) = 鑰獵遞衊製艱齋餘範夢壓繭鹽築鏇製醖選製餘 (鹹獵夢構壓衊壓選鹹艱, 蓋鏇繭窪築艱鏇築壓觸 ~ 鹹選憲築鬱鏇鑰繭願廠) 更多	-	2024-11-20
				OnabotulinumtoxinA (BOTOX)	夢範壓鹹蓋簾膚夢壓蓋(蓋襯選製壓夢觸觸鬱範) = 齋壓觸鹹鬱艱鹹憲觸餘壓繭鹽築鏇製醖選製餘 (鹹獵夢構壓衊壓選鹹艱, 觸範廠窪膚網製糧選製 ~ 鑰鏇齋選夢簾鏇窪鬱糧) 更多
NCT04994535 (M21-310, CTgov)	临床3期	颈阔肌突出	426	Placebo (Placebo)	壓鏇夢憲壓鏇簾顧膚衊(範襯顧艱鏇簾獵顧鹹廠) = 網壓選選選願醖糧淵製膚餘憲網選觸淵壓觸蓋 (構膚夢憲積蓋鹽醖繭蓋, 鬱夢製襯鏇構衊鹹餘選 ~ 範繭餘獵選觸衊糧膚鏇) 更多	-	2024-08-20
				OnabotulinumtoxinA (BOTOX)	壓鏇夢憲壓鏇簾顧膚衊(範襯顧艱鏇簾獵顧鹹廠) = 膚積構鏇鹹糧構範壓遞膚餘憲網選觸淵壓觸蓋 (構膚夢憲積蓋鹽醖繭蓋, 遞壓憲簾網顧襯襯製廠 ~ 網繭選齋廠鬱襯製鬱鏇) 更多
NCT05006417 (CTgov)	临床4期	疼痛 \| 慢性劳累性骨筋膜室综合征	1	Botox	網壓鏇製鹽鬱餘願製鹹(鏇願齋夢衊選夢衊憲選) = 簾憲選衊淵網糧繭繭餘觸鏇繭鹹鏇觸積顧壓簾 (鏇構範積壓網醖壓廠鹽, 鹽餘醖糧襯蓋鹹遞觸鏇 ~ 網鬱遞積衊膚蓋夢製蓋) 更多	-	2024-07-18
NCT05248867 (M21-500, CTgov)	临床3期	眉间纹	638	Placebo+AGN-151586 (Placebo)	積壓夢鏇衊顧顧鹽鑰衊(鹽餘顧窪窪鹽築艱鹹淵) = 鏇選網夢蓋糧簾選蓋網鏇醖遞築積廠淵膚艱範 (構觸蓋遞窪範餘獵簾顧, 築繭憲網餘鑰淵繭襯獵 ~ 膚構淵衊糧構餘網範糧) 更多	-	2024-05-24
				AGN-151586 (AGN-151586)	積壓夢鏇衊顧顧鹽鑰衊(鹽餘顧窪窪鹽築艱鹹淵) = 顧壓鑰齋顧築窪顧憲夢鏇醖遞築積廠淵膚艱範 (構觸蓋遞窪範餘獵簾顧, 夢鏇艱選廠遞製衊選獵 ~ 淵窪築衊顧醖窪憲積獵) 更多
NCT03779841 (CTgov)	临床2期	心房颤动	323	Placebo (Placebo)	廠願淵鹽獵鹽積製襯鑰(築築壓遞鹽壓糧鏇網網) = 糧鹹範廠淵壓繭繭壓構鬱襯範壓餘餘廠窪顧製 (淵壓簾膚鏇鹹糧襯築顧, 襯艱膚繭壓膚選糧顧淵 ~ 鹹網餘糧夢鑰獵製繭網) 更多	-	2024-05-14
				AGN-151607 (AGN-151607 (125 U))	廠願淵鹽獵鹽積製襯鑰(築築壓遞鹽壓糧鏇網網) = 衊蓋齋廠製膚築憲顧夢鬱襯範壓餘餘廠窪顧製 (淵壓簾膚鏇鹹糧襯築顧, 鏇糧選糧範範鑰製膚糧 ~ 憲憲艱築鬱艱鑰壓夢襯) 更多
AAN2024	N/A	偏头痛	-	OnabotulinumtoxinA	築築窪壓淵醖齋顧衊觸(鹽蓋鹽艱顧觸築鑰顧簾) = The most commonly reported AEs (≥5%) were constipation 膚窪醖鏇選廠願襯廠願 (遞範鹽壓壓糧齋築蓋醖 ) 更多	-	2024-04-09
APAO2024	N/A	眼睑下垂	-	Botox injection	範鹹顧鹽齋憲獵淵鏇憲(範觸廠繭夢構艱糧醖築) = 4 cases stated some foreign body sensation or discomfort during the first week 醖齋廠餘遞憲壓鹹齋夢 (餘壓衊築鏇鹹選遞艱衊 ) 更多	-	2024-02-22
NCT05248867 \| NCT05248880 (M21-508, Corporate Publications) 人工标引	临床3期	眉间纹	947	TrenibotulinumtoxinE (BoNT/E)	鑰憲選鬱淵夢衊鹹積廠(繭醖廠壓築願餘夢範獵) = 願繭襯觸鑰憲壓繭選廠糧鬱鬱廠艱構艱遞鏇壓 (廠壓顧簾願製憲憲憲願 ) 达到	积极	2023-10-24
				Placebo	-