Corticosteroids for Acute Migraine in the Emergency Department

Sponsor
Montefiore Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02847494
Collaborator
(none)
220
Enrollment
2
Locations
2
Arms
12.9
Actual Duration (Months)
110
Patients Per Site
8.5
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Sep 21, 2017
Actual Study Completion Date :
Sep 30, 2017

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Control

Metoclopramide 10mg IV+ dexamethasone 10mg IM

Drug: metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes

Drug: Dexamethasone
dexamethasone 10mg intramuscular injection

Active Comparator: Experimental

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

Drug: metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes

Drug: methylprednisolone acetate
methylprednislone acetate 160mg intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Headache Days as Self-reported by Participants [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 Outcome Measures

  1. Number of Participants With Sustained Headache Freedom [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 [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Montefiore Medical Center--EinsteinBronxNew YorkUnited States10461
2Montefiore Medical Center-MosesBronxNew YorkUnited States10467

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Benjamin W. Friedman, MD, PI, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT02847494
Other Study ID Numbers:
  • 2016-6342
First Posted:
Jul 28, 2016
Last Update Posted:
Jan 8, 2019
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleControlExperimental
Arm/Group DescriptionMetoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injectionMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Period Title: Overall Study
STARTED109111
COMPLETED101106
NOT COMPLETED85

Baseline Characteristics

Arm/Group TitleControlExperimentalTotal
Arm/Group DescriptionMetoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injectionMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injectionTotal of all reporting groups
Overall Participants109111220
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
36
(13)
39
(16)
38
(15)
Sex: Female, Male (Count of Participants)
Female
93
85.3%
94
84.7%
187
85%
Male
16
14.7%
17
15.3%
33
15%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (Count of Participants)
United States
109
100%
111
100%
220
100%
Duration of headache (hours) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [hours]
48
72
72

Outcome Measures

1. Primary Outcome
TitleHeadache Days as Self-reported by Participants
DescriptionAt the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
Time Frame7 days after discharge from emergency department

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleControlExperimental
Arm/Group DescriptionMetoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injectionMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Measure Participants101106
Mean (95% Confidence Interval) [days]
3.0
3.3
2. Secondary Outcome
TitleNumber of Participants With Sustained Headache Freedom
DescriptionSustained 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 Frame7 days after discharge from emergency department

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleControlExperimental
Arm/Group DescriptionMetoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injectionMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Measure Participants107110
Count of Participants [Participants]
10
9.2%
6
5.4%
3. Secondary Outcome
TitleMedication Preference as Assessed by Self-report
DescriptionParticipants 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 Frame7 days after discharge from emergency department

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleControlExperimental
Arm/Group DescriptionMetoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injectionMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Measure Participants101106
Count of Participants [Participants]
76
69.7%
75
67.6%

Adverse Events

Time Frame1 week
Adverse Event Reporting Description
Arm/Group TitleControlExperimental
Arm/Group DescriptionMetoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injectionMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
All Cause Mortality
ControlExperimental
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/109 (0%) 0/111 (0%)
Serious Adverse Events
ControlExperimental
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/109 (0%) 0/111 (0%)
Other (Not Including Serious) Adverse Events
ControlExperimental
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total3/109 (2.8%) 16/111 (14.4%)
Nervous system disorders
Akathisia2/109 (1.8%) 27/111 (6.3%) 7
Skin and subcutaneous tissue disorders
Injection site reaction1/109 (0.9%) 19/111 (8.1%) 9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleBenjamin W. Friedman, MD
OrganizationMontefiore Health
Phone17189206626
Emailbefriedm@montefiore.org
Responsible Party:
Benjamin W. Friedman, MD, PI, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT02847494
Other Study ID Numbers:
  • 2016-6342
First Posted:
Jul 28, 2016
Last Update Posted:
Jan 8, 2019
Last Verified:
Dec 1, 2018