NCT02847494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

July 25, 2016

Results QC Date

December 18, 2018

Last Update Submit

December 18, 2018

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants With Sustained Headache Freedom

    7 days after discharge from emergency department

  • Medication Preference as Assessed by Self-report

    7 days after discharge from emergency department

Study Arms (2)

Control

ACTIVE COMPARATOR

Metoclopramide 10mg IV+ dexamethasone 10mg IM

Drug: metoclopramideDrug: Dexamethasone

Experimental

ACTIVE COMPARATOR

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

Drug: metoclopramideDrug: methylprednisolone acetate

Interventions

metoclopramideDRUG

metoclopramide 10mg intravenous infusion over 15 minutes

ControlExperimental
DexamethasoneDRUG

dexamethasone 10mg intramuscular injection

Control
methylprednisolone acetateDRUG

methylprednislone acetate 160mg intramuscular injection

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Migraine without aura criteria (International Classification of Headache Disorders 3B )
  • Headache rated as moderate or severe in intensity

You may not qualify if:

  • Concern for secondary cause of headache
  • Contra-indications to investigational medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Medical Center--Einstein

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center-Moses

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • 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.

    PMID: 30449536DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

MetoclopramideDexamethasoneMethylprednisolone Acetate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedMethylprednisolonePrednisolone

Results Point of Contact

Title
Benjamin W. Friedman, MD
Organization
Montefiore Health
befriedm@montefiore.org
17189206626

Study Officials

  • Benjamin W Friedman, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

September 1, 2016

Primary Completion

September 21, 2017

Study Completion

September 30, 2017

Last Updated

January 8, 2019

Results First Posted

January 8, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)