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

Last updated: October 23, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Terminated

Phase

3

Condition

Pain (Pediatric)

Migraine (Pediatric)

Chronic Pain

Treatment

Ketoprofen

Placebo

Metoclopramide

Clinical Study ID

NCT04726592
CLORMIG
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 18 to 70

  • Patient suffering migraine or probable migraine (diagnosis made by neurologistaccording to IHCD3)

  • Present migraine attack lasting ≤ 72 hours

  • Headache intensity moderate or severe on the verbal ordinal scale (4 levels: noheadache, mild, moderate or severe)

  • Patient requiring parenteral treatment

  • Affiliation to the French Health-care System "sécurité sociale"

Exclusion

Exclusion Criteria:

  • abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/orDBP≥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 offailure of an anti-inflammatory drug at an effective dose taken within 6 hours

  • recent use of benzodiazepines (< 24h diazepam, clonazepam, clorazepate ; < 6halprazolam, 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 Design

Total Participants: 323
Treatment Group(s): 4
Primary Treatment: Ketoprofen
Phase: 3
Study Start date:
July 08, 2021
Estimated Completion Date:
April 10, 2024

Study 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.

Connect with a study center

  • Hôpital Lariboisière

    Paris, Ile-de-France 75010
    France

    Site Not Available

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