Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room
详细描述
Each patient will receive the usual migraine treatment: IV ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional IV metoclopramide 10 mg.
Depending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional IV Clorazepate 20 mg (study arm). The central pharmacy will be responsible for preparing the medications, using a double-blind protocol.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 70
- •Patient suffering migraine or probable migraine (diagnosis made by neurologist according to IHCD3)
- •Present migraine attack lasting ≤ 72 hours
- •Headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe)
- •Patient requiring parenteral treatment
- •Affiliation to the French Health-care System "sécurité sociale"
排除标准
- •abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/or DBP≥110 mmHg
- •suspicion of secondary headache
- •inability to understand the consent or scales
- •pregnancy or breast-feeding
- •known respiratory or liver insufficiency
- •acute alcohol consumption or alcoholism
- •myasthenia
- •Patient requiering treatment with sumatriptan SC, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours
- •recent use of benzodiazepines (< 24h diazepam, clonazepam, clorazepate ; < 6h alprazolam, lorazepam, midazolam)
- •recent use of pain killers (< 2h)
- •contraindication to any of the investigational medication
- •contraindication to intravenous access
- •previous participation to this study
研究组 & 干预措施
Experimental arm
clorazepate and standard care :
- Clorazepate 20 mg IV
- Ketoprofen 100 mg IV (if nausea-vomiting)
- Metoclopramide 10 mg IV(if nausea-vomiting)
干预措施: Metoclopramide (Drug)
Control arm
placebo and standard care :
- Placebo IV
- Ketoprofen 100 mg IV (if nausea-vomiting)
- Metoclopramide 10 mg IV(if nausea-vomiting)
干预措施: Placebo (Drug)
Control arm
placebo and standard care :
- Placebo IV
- Ketoprofen 100 mg IV (if nausea-vomiting)
- Metoclopramide 10 mg IV(if nausea-vomiting)
干预措施: Ketoprofen (Drug)
Control arm
placebo and standard care :
- Placebo IV
- Ketoprofen 100 mg IV (if nausea-vomiting)
- Metoclopramide 10 mg IV(if nausea-vomiting)
干预措施: Metoclopramide (Drug)
Experimental arm
clorazepate and standard care :
- Clorazepate 20 mg IV
- Ketoprofen 100 mg IV (if nausea-vomiting)
- Metoclopramide 10 mg IV(if nausea-vomiting)
干预措施: Clorazepate Dipotassium (Drug)
Experimental arm
clorazepate and standard care :
- Clorazepate 20 mg IV
- Ketoprofen 100 mg IV (if nausea-vomiting)
- Metoclopramide 10 mg IV(if nausea-vomiting)
干预措施: Ketoprofen (Drug)
结局指标
主要结局
Pain relief
时间窗: 2 hours
Percentage of patients "pain-relief" 2 hours after administration of the treatment
次要结局
未报告次要终点