Status:
TERMINATED
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Migraine
Migraine Without Aura
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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, pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT04726592
Start Date
July 8 2021
End Date
April 10 2024
Last Update
September 8 2025
Active Locations (1)
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1
Hôpital Lariboisière
Paris, Île-de-France Region, France, 75010