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

NCT04726592 | Terminated Phase 3

• 1 other identifier: P170903J
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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

Conditions

Migraine; Migraine Without Aura; Migraine With Aura; Headache

Outcome Measures

Primary Outcomes (1)

• Pain relief

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

  2 hours

Study Arms (2)

Control arm

PLACEBO COMPARATOR

placebo and standard care : * Placebo IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)

Drug: Placebo; Drug: Ketoprofen; Drug: Metoclopramide

Experimental arm

EXPERIMENTAL

clorazepate and standard care : * Clorazepate 20 mg IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)

Drug: Clorazepate Dipotassium; Drug: Ketoprofen; Drug: Metoclopramide

Interventions

Clorazepate Dipotassium DRUG

Clorazepate Dipotassium : 20 mg intravenous injection

Also known as: TRANXENE

Experimental arm

Placebo DRUG

Placebo IV

Control arm

Ketoprofen DRUG

Ketoprofen 100 mg IV

Control arm; Experimental arm

Metoclopramide DRUG

Metoclopramide 10 mg IV

Control arm; Experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Migraine Disorders; Migraine without Aura; Migraine with Aura; Headache

Interventions

Clorazepate Dipotassium; Ketoprofen; Metoclopramide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 27, 2021
• Study Start: July 8, 2021
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: September 8, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)