Corticosteroids for Acute Migraine in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02847494
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : December 12, 2017
Information provided by (Responsible Party):
Benjamin Friedman, 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: metoclopramide Drug: Dexamethasone Drug: methylprednisolone acetate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
Actual Study Start Date : September 1, 2016
Primary Completion Date : September 21, 2017
Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Headache days [ Time Frame: 1 week ]
    Number of days with headache during the week following emergency department discharge

Secondary Outcome Measures :
  1. Sustained headache freedom [ Time Frame: 1 week ]
    No headache at all during the week following emergency department discharge

  2. Preference [ Time Frame: 1 week ]
    Do you want to receive the same medication during a subsequent visit to the emergency department

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02847494

United States, New York
Montefiore Medical Center--Einstein
Bronx, New York, United States, 10461
Montefiore Medical Center-Moses
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.

Responsible Party: Benjamin Friedman, PI, Montefiore Medical Center Identifier: NCT02847494     History of Changes
Other Study ID Numbers: 2016-6342
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors