Corticosteroids for Acute Migraine in the Emergency Department

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847494
• Other study ID #: 2016-6342
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 30, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
• Dexamethasone
dexamethasone 10mg intramuscular injection
• methylprednisolone acetate
methylprednislone acetate 160mg intramuscular injection

Locations

Country	Name	City	State
United States	Montefiore Medical Center--Einstein	Bronx	New York
United States	Montefiore Medical Center-Moses	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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