Corticosteroids for Acute Migraine in the Emergency Department

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: methylprednisolone acetate; Drug: metoclopramide; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02847494

2016-6342

Details and patient eligibility

About

This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Migraine without aura criteria (International Classification of Headache Disorders 3B )
• Headache rated as moderate or severe in intensity

Exclusion criteria

• Concern for secondary cause of headache
• Contra-indications to investigational medications

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

220 participants in 2 patient groups

Control

Active Comparator group

Description:

Metoclopramide 10mg IV+ dexamethasone 10mg IM

Treatment:

Drug: Dexamethasone

Drug: metoclopramide

Experimental

Active Comparator group

Description:

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

Treatment:

Drug: methylprednisolone acetate

Drug: metoclopramide