Corticosteroids for Acute Migraine in the Emergency Department

NCT ID: NCT02847494

Last Updated: 2019-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Metoclopramide 10mg IV+ dexamethasone 10mg IM

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone

Intervention Type DRUG

dexamethasone 10mg intramuscular injection

Experimental

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

metoclopramide 10mg intravenous infusion over 15 minutes

methylprednisolone acetate

Intervention Type DRUG

methylprednislone acetate 160mg intramuscular injection

Interventions

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metoclopramide

metoclopramide 10mg intravenous infusion over 15 minutes

Intervention Type DRUG

Dexamethasone

dexamethasone 10mg intramuscular injection

Intervention Type DRUG

methylprednisolone acetate

methylprednislone acetate 160mg intramuscular injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Benjamin W. Friedman, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin W Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Montefiore Medical Center--Einstein

The Bronx, New York, United States

Site Status

Montefiore Medical Center-Moses

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30449536 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-6342

Identifier Type: -

Identifier Source: org_study_id

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