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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Clorazepate Dipotassium; Ketoprofen; Metoclopramide

Criteria

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