ALD403的安全性和有效性,降钙素相关基因肽的抗体,预防偏头痛频繁的情景:一个随机,双盲,安慰剂对照,探索第二阶段试验。

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西尔伯斯坦Dodick DW,戈德比PJ, SD, Lipton RB,奥尔森J, Ashina M,威尔K,库卓D, Kroll R, Kohrman B, Bargar R,史密斯Hirman J, J

ALD403的安全性和有效性,降钙素相关基因肽的抗体,预防偏头痛频繁的情景:一个随机,双盲,安慰剂对照,探索第二阶段试验。

柳叶刀神经。2014年11月,13 (11):1100 - 1107。doi: 10.1016 / s1474 - 4422 (14) 70209 - 1。Epub 2014 10月5。

PubMed ID

25297013 (在PubMed

]

文摘

背景:降钙素相关基因肽(CGRP怎样)偏头痛的病理生理学是至关重要的。我们评估了安全、耐受性和疗效ALD403,转基因人性化anti-CGRP抗体,预防偏头痛。方法:随机、双盲、安慰剂对照、探索性,概念验证第二阶段试验,偏头痛患者18-55岁5到14天每28天期被随机分配(1:1)通过一个交互式网络反应系统接受静脉注射剂量的ALD403 1000毫克或安慰剂。现场调查人员、病人和赞助商都蒙面治疗分配在研究过程中。主要的目标是评估安全输液后12周。主要疗效终点是改变在偏头痛的频率从基线到周5 - 8天,病人电子日记的记录。随访直到24周的探索性的安全性和有效性分析。安全性和有效性通过意图治疗分析。这项研究是在ClinicalTrials.gov注册,NCT01772524。发现:在2013年1月28日,12月23日,2013年,26岁的174名患者随机分配中心在美国,163收到ALD403 (n = 81)或安慰剂(n = 82)。 Adverse events were experienced by 46 (57%) of 81 patients in the ALD403 group and 43 (52%) of 82 in the placebo group. The most frequent adverse events were upper respiratory tract infection (placebo 6 [7%] patients vs ALD403 7 [9%] patients), urinary tract infection (4 [5%] vs 1 [1%]), fatigue (3 [4%] vs 3 [4%]), back pain (4 [5%] vs 3 [4%]), arthralgia (4 [5%] vs 1 [1%]), and nausea and vomiting (2 [2%] vs 3 [4%]). Six serious adverse events were reported by three patients and were judged to be unrelated to study drug: in the ALD403 group, one patient had four serious adverse events and one had one serious adverse event, and in the placebo group, one patient had one serious adverse event. There were no differences in vital signs or laboratory safety data between the two treatment groups. The mean change in migraine days between baseline and weeks 5-8 was -5.6 (SD 3.0) for the ALD403 group compared with -4.6 (3.6) for the placebo group (difference -1.0, 95% CI -2.0 to 0.1; one-sided p=0.0306). INTERPRETATION: No safety concerns were noted with an intravenous dose of ALD403 1000 mg. This study also provides preliminary evidence for the efficacy of ALD403 in the preventive treatment of migraine in patients with a high monthly frequency of migraine days. FUNDING: Alder Biopharmaceuticals.

DrugBank数据引用了这篇文章

药物

Eptinezumab

Galcanezumab

药物靶点

药物	目标	类	生物	药理作用	行动
Eptinezumab	降钙素相关基因肽1	蛋白质	人类	是的	粘结剂 抗体	细节
Eptinezumab	降钙素相关基因肽2	蛋白质	人类	是的	粘结剂 抗体	细节