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Safety and efficacy of a Nav1.7 selective sodium channel blocker in patients with trigeminal neuralgia: a double-blind, placebo-controlled, randomised withdrawal phase 2a trial

机译:Nav1.7选择性钠通道阻滞剂在三叉神经痛患者中的安全性和有效性:一项双盲,安慰剂对照,随机退出的2a期试验

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摘要

Current standard of care for trigeminal neuralgia is treatment with the sodium channel blockers carbamazepine and oxcarbazepine, which although effective are associated with poor tolerability and the need for titration. BIIB074, a Nav1.7-selective, state-dependent sodium-channel blocker, can be administered at therapeutic doses without titration, and has shown good tolerability in healthy individuals in phase 1 studies. We therefore assessed the safety and efficacy of BIIB074 in patients with trigeminal neuralgia in a phase 2a study.
机译:三叉神经痛的当前护理标准是用钠通道阻滞剂卡马西平和奥卡西平治疗,尽管有效,但耐受性差,需要滴定。 BIIB074是一种Nav1.7选择性的,依赖状态的钠通道阻滞剂,可以不滴定的治疗剂量给药,并且在1期研究中对健康个体显示出良好的耐受性。因此,我们在2a期研究中评估了BIIB074在三叉神经痛患者中的安全性和有效性。

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