CTRI/2022/10/046474进行中（未招募）不适用
To study the effectiveness and safety of prochlorperazine in patients suffering from vestibular migraine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 259
- 试验地点
- 5
- 主要终点
- •Number and proportion of MAV patients achieving improvement in Clinical Response, described as worsening (increased by 1 level), no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels), as graded using SVVSLCRE, from baseline (day 0) to day 6, day 15, and day 30.
研究概览
简要总结
NA
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients in the age group of 18-65 years 2.Patients diagnosed of vestibular migraine based on to ICHD-3 criteria9 3.Patient who has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure.
排除标准
- •1.Patients on prochlorperazine or any other anti-vertigo therapy drugs in the past 30 days 2.Patients with history of psychiatric illness in the past 6 months 3.Patients on anti-psychotic or anti-depressant medication in the past 6 months 4.Patients with history of cardiovascular, kidney or liver disorder 5.Patients with suspected or established subcortical brain damage, with or without hypothalamic damage 6.Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating.
结局指标
主要结局
•Number and proportion of MAV patients achieving improvement in Clinical Response, described as worsening (increased by 1 level), no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels), as graded using SVVSLCRE, from baseline (day 0) to day 6, day 15, and day 30.
时间窗: Baseline (day 0) to day 6, day 15, and day 30.
Clinical Response will be assessed using SVVSLRE reading. Clinical response is described as worsening, no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels). [Moderate, Good, Very Good, Excellent]
时间窗: Baseline (day 0) to day 6, day 15, and day 30.
次要结局
- Number and proportion of patients with improvement in symptoms assessed using scale of vestibular vertigo severity level from baseline to end of treatment period. Symptom severity is graded on the SVVSLCRE (Level I [0–2] absent vestibular vertigo Level V [8-10], very severe vestibular vertigo). The severity of vertigo-associated symptoms (faintness headache, hearing loss, nausea, vomiting, and tinnitus) will be assessed, and symptom severity will be graded based on SVVSLCRE(Baseline (day 0) to day 6, day 15, and day 30.)
研究者
研究点 (5)
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