Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room (CLORMIG)

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

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

Study Overview

• Status: Terminated
• Conditions: Migraine; Headache; Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Drug: Placebo; Drug: Ketoprofen; Drug: Metoclopramide; Drug: Clorazepate Dipotassium

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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • Hôpital Lariboisière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Migraine with Aura; Migraine without Aura; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Substandard Drugs; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Amides; Phenols; Benzene Derivatives; Benzazepines; Acids, Carbocyclic; para-Aminobenzoates; Aminobenzoates; Benzoates; Hydroxybenzoates; Benzodiazepines; Phenyl Ethers; Benzamides; Chlorobenzoates; Phenylpropionates; Hydroxybenzoate Ethers; Ketoprofen; Clorazepate Dipotassium; Metoclopramide; Counterfeit Drugs
• Other Study ID Numbers: P170903J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No