A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sensorion
- 入组人数
- 107
- 试验地点
- 24
- 主要终点
- Standing Vertigo Intensity
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SENS-111 100mg
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
干预措施: SENS-111 100mg (Drug)
SENS-111 200mg
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
干预措施: SENS-111 200mg (Drug)
Placebo
Placebo: 2 placebo Oral Dispersible Tablets
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Standing Vertigo Intensity
时间窗: over the 4 treatment days
The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
次要结局
- Worst Spontaneous Vertigo Intensity(over the 4 treatment days)
- Proprioception D5(End of treatment Day 5)
- Proprioception D28(End of study Day 28)
- Vestibular Spontaneous Nystagmus D5(End of treatment Day 5 compared to basleine)
- Vestibular Spontaneous Nystagmus D28(28 days compared to baseline)
- Nausea Severity(over the 4 Treatment Days (Day 5))