Corticosteroids for Acute Migraine in the Emergency Department

Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: metoclopramide; Drug: Dexamethasone; Drug: methylprednisolone acetate

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center-Moses
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center--Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Metoclopramide 10mg IV+ dexamethasone 10mg IM	Drug: metoclopramide; metoclopramide 10mg intravenous infusion over 15 minutes; Drug: Dexamethasone; dexamethasone 10mg intramuscular injection
Active Comparator: Experimental; Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM	Drug: metoclopramide; metoclopramide 10mg intravenous infusion over 15 minutes; Drug: methylprednisolone acetate; methylprednislone acetate 160mg intramuscular injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Sustained Headache Freedom	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.	7 days after discharge from emergency department
Medication Preference as Assessed by Self-report	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".	7 days after discharge from emergency department

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Publications and helpful links

General Publications

• Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 21, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Metoclopramide
• Other Study ID Numbers: 2016-6342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No