Motion Syros：曲哌立吞对晕动病治疗有效；一项多中心、随机、双盲、安慰剂对照研究。
Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study.
作者信息
Polymeropoulos Vasilios M, Kiely Leah, Bushman Margaret L, Sutherland E Blake, Goldberg Abigail R, Pham Annalise X, Miller Cameron R, Mourad Raina, Davis Tanner R, Pham Nikolas V, Morgan Dane B, Giles Abigail K, Xiao Changfu, Polymeropoulos Christos M, Birznieks Gunther, Polymeropoulos Mihael H
机构信息
Vanda Pharmaceuticals Inc., Washington, DC, United States.
出版信息
Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025.
INTRODUCTION
Motion sickness has afflicted travelers since ancient times. Neurokinin-1 (NK1) receptor antagonists have therapeutic potential as treatments for the symptoms of motion sickness due to the widespread expression of NK1 receptors throughout important locations in the emetic pathway in the network of brainstem nuclei and the gut. This study evaluated the efficacy of tradipitant, a novel NK1 receptor antagonist, in preventing motion sickness symptoms in variable sea conditions.
METHODS
A total of 365 adult participants with a history of motion sickness embarked on boat trips under variable sea conditions. Study participants were distributed across 34 boat trips that took place between November 2021 and April 2023 in coastal waters of the United States. Participants were randomized 1:1:1 and received 170 mg tradipitant ( = 120), 85 mg tradipitant ( = 123) or placebo ( = 122). The symptoms of vomiting and nausea were evaluated with questionnaires every 30 min during the approximately four-hour trips. The primary efficacy endpoint for the study was the percentage of vomiting during vehicle travel. Statistical hypothesis testing was performed at the two-sided alpha level of 0.05 unless specified otherwise. Tests were declared statistically significant if the calculated -value was ≤ 0.05.
RESULTS
The incidence of vomiting in both dosing arms of tradipitant was significantly lower than the placebo group across all boat trips (170 mg tradipitant = 18.3%, 85 mg tradipitant = 19.5%, placebo = 44.3%, < 0.0001 for both dose comparisons against placebo). Tradipitant prevented severe nausea and vomiting as compared to participants taking placebo (tradipitant = 18.03%, placebo = 37.70%, < 0.0001).
DISCUSSION
Tradipitant 170 mg and 85 mg have been confirmed to be effective in the prevention of vomiting associated with motion sickness across varied sea conditions.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT04327661.
引言
晕动病自古以来就一直困扰着旅行者。神经激肽-1（NK1）受体拮抗剂具有治疗晕动病症状的潜力，因为NK1受体在脑干核网络和肠道的催吐途径中的重要位置广泛表达。本研究评估了新型NK1受体拮抗剂曲吡那敏在不同海况下预防晕动病症状的疗效。
方法
共有365名有晕动病史的成年参与者在不同海况下乘船旅行。研究参与者分布在美国沿海水域2021年11月至2023年4月期间进行的34次乘船旅行中。参与者按1:1:1随机分组，分别接受170毫克曲吡那敏（n = 120）、85毫克曲吡那敏（n = 123）或安慰剂（n = 122）。在大约四小时的旅行中，每30分钟通过问卷评估呕吐和恶心症状。该研究的主要疗效终点是乘车旅行期间呕吐的百分比。除非另有规定，统计假设检验在双侧α水平为0.05下进行。如果计算出的P值≤0.05，则试验被宣布具有统计学意义。
结果
在所有乘船旅行中，曲吡那敏两个给药组的呕吐发生率均显著低于安慰剂组（170毫克曲吡那敏 = 18.3%，85毫克曲吡那敏 = 19.5%，安慰剂 = 44.3%，两种剂量与安慰剂比较P均<0.0001）。与服用安慰剂的参与者相比，曲吡那敏可预防严重的恶心和呕吐（曲吡那敏 = 18.03%，安慰剂 = 37.70%，P<0.0001）。
讨论
已证实170毫克和85毫克的曲吡那敏在预防不同海况下与晕动病相关的呕吐方面有效。
临床试验注册
ClinicalTrials.gov，标识符NCT04327661。
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