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

Phase 3

Terminated

• Conditions: Migraine; Migraine Without Aura; Migraine with Aura; Headache
• Interventions: Drug: Clorazepate Dipotassium; Drug: Placebo; Drug: Ketoprofen; Drug: Metoclopramide

• Registration Number: NCT04726592
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Study Start: 2021-07-08
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 323

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Clorazepate Dipotassium	clorazepate and standard care : * Clorazepate 20 mg IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)
Control arm	Placebo	placebo and standard care : * Placebo IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)
Control arm	Ketoprofen	placebo and standard care : * Placebo IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)
Control arm	Metoclopramide	placebo and standard care : * Placebo IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)
Experimental arm	Ketoprofen	clorazepate and standard care : * Clorazepate 20 mg IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)
Experimental arm	Metoclopramide	clorazepate and standard care : * Clorazepate 20 mg IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting)

Primary Outcome Measures

Name	Time	Method
Pain relief	2 hours	Percentage of patients "pain-relief" 2 hours after administration of the treatment

Trial Locations

Locations (1)

Hôpital Lariboisière; 🇫🇷 Paris, Ile-de-France, France