Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

Conditions
-----------------
Migraine, Migraine Without Aura, Migraine With Aura, Headache

Intervention / Treatment
-----------------
* Drug: Clorazepate Dipotassium
* Drug: Placebo
* Drug: Ketoprofen
* Drug: Metoclopramide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control arm<br>placebo and standard care : Placebo IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting) | Drug: Placebo<br>* Placebo IV<br>Drug: Ketoprofen<br>* Ketoprofen 100 mg IV<br>Drug: Metoclopramide<br>* Metoclopramide 10 mg IV<br>|
| Experimental: Experimental arm<br>clorazepate and standard care : Clorazepate 20 mg IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting) | Drug: Clorazepate Dipotassium<br>* Clorazepate Dipotassium : 20 mg intravenous injection<br>* Other names: TRANXENE;Drug: Ketoprofen<br>* Ketoprofen 100 mg IV<br>Drug: Metoclopramide<br>* Metoclopramide 10 mg IV<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Percentage of patients pain-relief 2 hours after administration of the treatment | 2 hours |