Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
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, 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 Type: Interventional (Clinical Trial)
Estimated 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: July 8, 2021
Estimated Primary Completion Date: December 1, 2024
Estimated Study Completion Date: December 1, 2024
Arms:
- Placebo Comparator: Control arm
- Experimental: Experimental arm
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 420 |
| Actual Study start date | 08 July 2021 |
| Estimated study completion date | 01 December 2024 |