Braverman Itzhak, Elziere Maya, Komazec Zoran, Cohen-Vaizer Mauricio, Kalcioglu Mahmut Tayyar, Chrobok Viktor, Kazmer Igor, Hilly Ohad, Esteve-Fraysse Marie Jose, Doweck Ilana, Glotin Anne-Lise, Fitoussi Serge, Laredo Judith, Honnet Geraldine
Hillel Yaffe Medical Centre, Ha'shalom, PObox 169, 38100 Hadera, Israel.
Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 Marseille, France.
Am J Otolaryngol. 2024 Nov-Dec;45(6):104480. doi: 10.1016/j.amjoto.2024.104480. Epub 2024 Aug 8.
Safety and efficacy of SENS-401, a serotonin type 3 (5-HT) receptor antagonist and calcineurin inhibitor, in patients with acute sudden sensorineural hearing loss (SSNHL).
Multicentre randomized, double blind, placebo-controlled trial enrolled adult subjects with sudden sensorineural hearing loss (SSNHL) or unilateral/bilateral acute acoustic trauma leading to SSNHL within 96 h of disease onset. Subjects were randomly assigned to one of the three oral dose groups: 29 mg, 43.5 mg or placebo given twice daily for 28 days. The primary endpoint was the change from baseline in Pure Tone Average (PTA) in the affected ear to the end of treatment visit (day 28). Subjects were further followed up 8 weeks after the end of the treatment period (day 84).
A total of 115 subjects were randomized. SENS-401 was well tolerated. Although the primary efficacy endpoint was not met at day 28, post-hoc analyses revealed clinically significant and meaningful efficacy outcomes with SENS-401 when compared to placebo in a substantial group of participants diagnosed with idiopathic SSNHL and who had received corticosteroid treatment. Notable improvements were observed in the PTA change from baseline, the complete hearing recovery rate, and the Word Recognition Score (WRS), particularly at day 84. The responder rate consistently favored treated subjects over those who received the placebo.
While the primary endpoint was not achieved at the end of the treatment period, the study revealed consistently positive efficacy results of clinical relevance in patients with idiopathic SSNHL who received SENS-401, particularly in the 8-weeks follow-up phase after the completion of the treatment.
评估血清素3型（5-HT）受体拮抗剂和钙调神经磷酸酶抑制剂SENS-401治疗急性突发性感音神经性听力损失（SSNHL）患者的安全性和有效性。
一项多中心随机、双盲、安慰剂对照试验，纳入发病96小时内出现突发性感音神经性听力损失（SSNHL）或单侧/双侧急性声创伤导致SSNHL的成年受试者。受试者被随机分配到三个口服剂量组之一：29毫克、43.5毫克或安慰剂，每日两次，共28天。主要终点是患耳纯音平均听阈（PTA）从基线到治疗结束访视（第28天）的变化。在治疗期结束后8周（第84天）对受试者进行进一步随访。
共有115名受试者被随机分组。SENS-401耐受性良好。虽然在第28天时未达到主要疗效终点，但事后分析显示，在一组被诊断为特发性SSNHL且接受过皮质类固醇治疗的参与者中，与安慰剂相比，SENS-401具有临床显著且有意义的疗效结果。在PTA从基线的变化、完全听力恢复率和单词识别分数（WRS）方面观察到显著改善，尤其是在第84天。应答率始终有利于接受治疗的受试者，而不是接受安慰剂的受试者。
虽然在治疗期结束时未达到主要终点，但该研究显示，接受SENS-401治疗的特发性SSNHL患者始终具有临床相关的积极疗效结果，尤其是在治疗完成后的8周随访期。
