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Completed

NCT Number: NCT02847494

Corticosteroids for Acute Migraine in the Emergency Department

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center--Einstein, The Bronx, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoclopramide

Drug

metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone

Drug

dexamethasone 10mg intramuscular injection

Methylprednisolone Acetate

Drug

methylprednislone acetate 160mg intramuscular injection

Primary outcomes

  1. Headache Days as Self-reported by Participants

    Time frame: 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 outcomes

  1. Number of Participants With Sustained Headache Freedom

    Time frame: 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.

  2. Medication Preference as Assessed by Self-report

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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