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Corticosteroids for Acute Migraine in the Emergency Department

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
metoclopramide
Dexamethasone
methylprednisolone acetate
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center--Einstein
  • Montefiore Medical Center-Moses

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control

Experimental

Arm Description

Metoclopramide 10mg IV+ dexamethasone 10mg IM

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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".

Full Information

First Posted
July 25, 2016
Last Updated
December 18, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02847494
Brief Title
Corticosteroids for Acute Migraine in the Emergency Department
Official Title
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Metoclopramide 10mg IV+ dexamethasone 10mg IM
Arm Title
Experimental
Arm Type
Active Comparator
Arm Description
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Description
metoclopramide 10mg intravenous infusion over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone 10mg intramuscular injection
Intervention Type
Drug
Intervention Name(s)
methylprednisolone acetate
Intervention Description
methylprednislone acetate 160mg intramuscular injection
Primary Outcome Measure Information:
Title
Headache Days as Self-reported by Participants
Description
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
Time Frame
7 days after discharge from emergency department
Secondary Outcome Measure Information:
Title
Number of Participants With Sustained Headache Freedom
Description
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.
Time Frame
7 days after discharge from emergency department
Title
Medication Preference as Assessed by Self-report
Description
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".
Time Frame
7 days after discharge from emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center--Einstein
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center-Moses
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30449536
Citation
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.
Results Reference
derived

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Corticosteroids for Acute Migraine in the Emergency Department

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