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

NCT ID: NCT04726592

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2024-04-10

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.

Conditions

Migraine; Migraine Without Aura; Migraine With Aura; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control arm

placebo and standard care :

• Placebo IV
• Ketoprofen 100 mg IV (if nausea-vomiting)
• Metoclopramide 10 mg IV(if nausea-vomiting)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo IV

Ketoprofen

Intervention Type: DRUG

Ketoprofen 100 mg IV

Metoclopramide

Intervention Type: DRUG

Metoclopramide 10 mg IV

Experimental arm

clorazepate and standard care :

• Clorazepate 20 mg IV
• Ketoprofen 100 mg IV (if nausea-vomiting)
• Metoclopramide 10 mg IV(if nausea-vomiting)

Group Type: EXPERIMENTAL

Clorazepate Dipotassium

Intervention Type: DRUG

Clorazepate Dipotassium : 20 mg intravenous injection

Ketoprofen

Intervention Type: DRUG

Ketoprofen 100 mg IV

Metoclopramide

Intervention Type: DRUG

Metoclopramide 10 mg IV

Interventions

Clorazepate Dipotassium

Clorazepate Dipotassium : 20 mg intravenous injection

Intervention Type: DRUG

Placebo

Placebo IV

Intervention Type: DRUG

Ketoprofen

Ketoprofen 100 mg IV

Intervention Type: DRUG

Metoclopramide

Metoclopramide 10 mg IV

Intervention Type: DRUG

Other Intervention Names

TRANXENE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Lariboisière

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

P170903J

Identifier Type: -

Identifier Source: org_study_id