NCT04726592

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Migraine Without Aura
• Migraine With Aura
• Headache

Interventions

Type	Name	Description
DRUG	Clorazepate Dipotassium	Clorazepate Dipotassium : 20 mg intravenous injection
DRUG	Placebo	Placebo IV
DRUG	Ketoprofen	Ketoprofen 100 mg IV
DRUG	Metoclopramide	Metoclopramide 10 mg IV

Timeline

• Start date: 2021-07-08
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2021-01-27
• Last updated: 2025-09-08

Locations

1 site across 1 country: France