Randomized, double-blind, single-centre, randomized study evaluating the efficacy of CLORazepate dipotassium in the treatment of migraine crisis in the emergency department. - CLORMIG

Assistance Publique- Hôpiaux de Paris0 个研究点目标入组 420 人开始时间: 2020年6月8日最近更新: 2024年6月3日

适应症

试验速览

暂无简介。

•Patient 18 to 70 years old
•- Patient with a migraine or probable migraine, with or without aura, episodic or chronic, meeting the IHCD3 (International Classification of Headache Disorders 3rd edition) criteria, the diagnosis being made by a neurologist.
•- Crisis of a duration = 72h
•- Intensity of moderate or severe headache on the ordinal verbal pain scale
•- Patient affiliated to a social security scheme
•Translated with www.DeepL.com/Translator (free version)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 420
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 420

•- Abnormalities of neurological examination, coma attack and/or fever (temperature = 38°C), PAS=180 and/or PAD=110 mmHg
•- Suspicion of secondary headache
•- Inability to understand informed consent or questionnaires
•- Pregnancy and breastfeeding
•- Known respiratory insufficiency and/or sleep apnea
•- Known liver failure
•- Acute or chronic alcohol poisoning
•- Myasthenia gravis
•- Recent use of benzodiazepines
•o < 24h for long-acting benzodiazepines (diazepam, clonazepam, CDP)
•o < 6 hours for shorter acting benzodiazepines (alprazolam, lorazepam, midazolam)
•- Taking recent analgesics (<2h)
•- Allergy, or known hypersensitivity and/or other contraindications to CDP, another benzodiazepine, ketoprofen and/or metoclopramide
•- Contraindication to the use of an intravenous approach
•- Patient who has already participated in this study
•- Patient participating in other research involving the human person

发起方

Assistance Publique- Hôpiaux de Paris