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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726592
• Other study ID #: CLORMIG
• Status: Recruiting
• Phase: Phase 3
• Start date: July 8, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jérôme Dr MAWET
• Phone: 01 49 95 24 77
• Email: jerome.mawet[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Headache
• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Intervention

Drug:
• Clorazepate Dipotassium
Clorazepate Dipotassium : 20 mg intravenous injection
• Placebo
Placebo IV
• Ketoprofen
Ketoprofen 100 mg IV
• Metoclopramide
Metoclopramide 10 mg IV

Locations

Country	Name	City	State
France	Hôpital Lariboisière	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Percentage of patients "pain-relief" 2 hours after administration of the treatment	2 hours