文摘
摘要目的:检查ubrogepant影响patient-reported功能残疾,满意度研究药物,和头痛缓解2关键阶段3的研究。
背景:Ubrogepant是一本小说,口服CGRP怎样发展受体拮抗剂对急性治疗偏头痛。
设计/方法:两个多中心,双盲,单一攻击,第三阶段的研究。成人偏头痛患者随机安慰剂,ubrogepant 50毫克,或ubrogepant 100毫克(实现),或安慰剂,ubrogepant 25毫克,或ubrogepant 50毫克(达到II)。单项功能残疾量表测量病人的日常活动能力,4回答选项。Patient-reported满意度研究药物和患者的全球印象改变测量用单项级等级量表。
结果:1327年和1355年的患者被随机分配实现I和II,分别。在2小时,一个更高比例的ubrogepant-treated病人报告能够正常运转(实现我50 mg: 41%,P= 0.0012;100毫克:43%,P< 0.0001;实现二25 mg: 43%,P= 0.0015;50毫克:41%,P= 0.0118);满意/非常满意研究药物(实现我50 mg: 36%,P< 0.0001;100毫克:36%,P= 0.0002;实现二25 mg: 35%,P= 0.0018;50毫克:38%,P< 0.0001);偏头痛,表示他们很/非常好(实现我50 mg: 34%,P= 0.0006;100毫克:34%,P= 0.0009;实现二25 mg: 34%,P< 0.0001;50毫克:33%,P= 0.0002)和安慰剂。在2小时后剂量,疼痛自由(实现我50 mg: 19%,P= 0.0023;100毫克:21%,P= 0.0003;实现二25 mg: 21%,P= 0.0285;50毫克:22%,P= 0.0129)和缓解疼痛(实现我50毫克,100 mg: 61%,P= 0.0023;实现二25 mg: 61%,P= 0.0711;50毫克:63%,Pubrogepant-treated患者= 0.0129)显著高于安慰剂。
结论:在两种试验更高比例的ubrogepant比接受安慰剂的患者报告的正常功能和整体满意度治疗偏头痛,表示他们是更好的。这些以病人为中心的结果的结果被发现有临床意义和加强的潜在好处ubrogepant偏头痛的急性治疗。
披露:Viswanathan博士已经收到个人赔偿咨询、担任科学顾问委员会说,爱力根或其他活动,Inc . Viswanathan博士持有股票或股票期权在爱力根,Inc .科研博士Viswanathan卷入作为调查员。Viswanathan博士持有股票或股票期权,爱力根公司立顿博士已经收到个人赔偿咨询、担任科学顾问委员会说,与美国神经病学学会或其他活动,桤木生物制药,爱力根,美国头痛学会安进,自主技术,Avanir制药、Biohaven, Biovision,波士顿科学,Reddy博士的,Electrocore,礼来,eNeura疗法,默克,Pernix,辉瑞、葛兰素史克Supernus, Teva, Trigemina,向量,韦丹塔。首页立顿博士在Biohaven持有股票或股票期权。Ailani博士已经收到个人赔偿咨询、担任科学顾问委员会说,与桤木或其他活动,爱力根,安进,Avanir, Biohavin,礼来公司,Electrocore, Promius, Teva,推动、无核小蜜橘,Aptus, Alpha网站和米勒医疗通信。Ailani博士已经收到了个人在一篇社论中补偿能力目前的疼痛和头痛报告(部分编辑)。Ailani博士收到ARMR研究支持/美国偏头痛基金会和Biohaven。Halker博士已经收到个人赔偿咨询、担任科学顾问委员会说,WebMD / Medlink或其他活动,安进,爱力根。Halker博士已经收到了个人在一篇社论中补偿电流神经病学和神经科学报告的能力。首页Shewale博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动,爱力根公司的全职员工。Shewale博士持有股票或股票期权在艾尔建公司赞助的研究Shewale博士是作为一个侦探。 Dr. Zhao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Inc. Dr. Trugman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan plc. Dr. Trugman holds stock and/or stock options in Allergan plc. which sponsored research in which Dr. Trugman was involved as an investigator. Dr. Trugman holds stock and/or stock options in Allergan plc. Dr. Yu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Inc.. Dr. Dodick has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Dodick reports personal fees from Acorda, Amgen, Alder, Allergan, Autonomic Technologies, Biohaven, Colucid, Eli Lilly, eNeura, Foresight Capital, Neurolief, Zosano, WL Gore, Vedanta Associates, Promius Pharma, Magellan Healthcare, CC West Ford Group, Nocira, Novartis, NuPathe, Supernus, Electrocore, Tonix, Teva, Alcobra, Insys, Ipsen, Charleston Laboratories, Biocentric, Theranica, Xenon. ZP Opco. Travel expense reimbursement and speaking fee from Sun Pharma. Anticipated income from consulting within next 3 weeks not previously reported: Impel pharmaceuticals (currently under review by Mayo Clinic Medical Industry Relations Committee). Compensation for activities related to data safety monitoring committee from Axsome. Speaking fees, or fees related to CME content development: Healthlogix, Medicom Worldwide, Medlogix Communications, MedNet, Miller Medical Communications, PeerView Operation Services America, Web MD/Medscape, American Academy of Neurology, American Headache Society, PeerView Institute for Medical Education, Chameleon Communications, Academy for Continued Healthcare Learning, Universal Meeting Management, Haymarket Medical Education, Global Scientific Communications, UpToDate, Meeting LogiX. Consulting use agreement through employer: NeuroAssessment Systems, Myndshft. Dr. Dodick has received compensation for serving on the Board of Directors of Board of Directors position: King-Devick Technologies, Ontologics. Dr. Dodick holds stock and/or stock options in Hold equity in: Aural Analytics, Healint, Theranica, Second Opinion/Mobile Health, Epien, which sponsored research in which Dr. Dodick was involved as an investigator. Dr. Dodick holds stock and/or stock options in Hold equity in: Aural Analytics, Healint, Theranica, Second Opinion/Mobile Health, and Epien.
