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

December 12, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75010
        • Recruiting
        • Hôpital Lariboisière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 hours
Percentage of patients "pain-relief" 2 hours after administration of the treatment
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 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)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLORMIG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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