Corticosteroids for Acute Migraine in the Emergency Department

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: metoclopramide; Drug: methylprednisolone acetate; Drug: Dexamethasone

• Registration Number: NCT02847494
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-09-01
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-30
• Status Verified: 2018-12
• Results First Submitted: 2018-12-18
• Results First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Results First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	methylprednisolone acetate	Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
Control	metoclopramide	Metoclopramide 10mg IV+ dexamethasone 10mg IM
Experimental	metoclopramide	Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
Control	Dexamethasone	Metoclopramide 10mg IV+ dexamethasone 10mg IM

Primary Outcome Measures

Name	Time	Method
Headache Days as Self-reported by Participants	7 days after discharge from emergency department	At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Headache Freedom	7 days after discharge from emergency department	Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge.
Medication Preference as Assessed by Self-report	7 days after discharge from emergency department	Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes".

Trial Locations

Locations (2)

Montefiore Medical Center-Moses; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center--Einstein; 🇺🇸 Bronx, New York, United States