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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04726592
Other study ID # CLORMIG
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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