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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04726592

Collaborator

(none)

420

Enrollment

Location

Arms

40.8

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Migraine Migraine Without Aura Migraine With Aura Headache	Drug: Clorazepate Dipotassium Drug: Placebo Drug: Ketoprofen Drug: Metoclopramide	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 8, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control arm placebo and standard care : Placebo IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting)	Drug: Placebo Placebo IV Drug: Ketoprofen Ketoprofen 100 mg IV Drug: Metoclopramide Metoclopramide 10 mg IV
Experimental: Experimental arm 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 Clorazepate Dipotassium : 20 mg intravenous injection Other Names: TRANXENE Drug: Ketoprofen Ketoprofen 100 mg IV Drug: Metoclopramide Metoclopramide 10 mg IV

Arm

Intervention/Treatment

Placebo Comparator: Control arm

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

Drug: Placebo

Placebo IV

Drug: Ketoprofen

Ketoprofen 100 mg IV

Drug: Metoclopramide

Metoclopramide 10 mg IV

Experimental: Experimental arm

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

Clorazepate Dipotassium : 20 mg intravenous injection

Other Names:

TRANXENE

Drug: Ketoprofen

Ketoprofen 100 mg IV

Drug: Metoclopramide

Metoclopramide 10 mg IV

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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