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Corticosteroids for Acute Migraine in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02847494
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Migraine
Interventions Drug: metoclopramide
Drug: Dexamethasone
Drug: methylprednisolone acetate
Enrollment 220
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Experimental
Hide Arm/Group Description

Metoclopramide 10mg IV+ dexamethasone 10mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone: dexamethasone 10mg intramuscular injection

Metoclopramide 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
Started 109 111
Completed 101 106
Not Completed 8 5
Reason Not Completed
Lost to Follow-up             8             5
Arm/Group Title Control Experimental Total
Hide Arm/Group Description

Metoclopramide 10mg IV+ dexamethasone 10mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone: dexamethasone 10mg intramuscular injection

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection

Total of all reporting groups
Overall Number of Baseline Participants 109 111 220
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 111 participants 220 participants
36  (13) 39  (16) 38  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 111 participants 220 participants
Female
93
  85.3%
94
  84.7%
187
  85.0%
Male
16
  14.7%
17
  15.3%
33
  15.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 109 participants 111 participants 220 participants
109
 100.0%
111
 100.0%
220
 100.0%
Duration of headache  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 109 participants 111 participants 220 participants
48
(24 to 96)
72
(24 to 120)
72
(24 to 96)
1.Primary Outcome
Title Headache Days as Self-reported by Participants
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Metoclopramide 10mg IV+ dexamethasone 10mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone: dexamethasone 10mg intramuscular injection

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection

Overall Number of Participants Analyzed 101 106
Mean (95% Confidence Interval)
Unit of Measure: days
3.0
(2.5 to 3.5)
3.3
(2.8 to 3.9)
2.Secondary Outcome
Title Number of Participants With Sustained Headache Freedom
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Metoclopramide 10mg IV+ dexamethasone 10mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone: dexamethasone 10mg intramuscular injection

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection

Overall Number of Participants Analyzed 107 110
Measure Type: Count of Participants
Unit of Measure: Participants
10
   9.3%
6
   5.5%
3.Secondary Outcome
Title Medication Preference as Assessed by Self-report
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Metoclopramide 10mg IV+ dexamethasone 10mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone: dexamethasone 10mg intramuscular injection

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection

Overall Number of Participants Analyzed 101 106
Measure Type: Count of Participants
Unit of Measure: Participants
76
  75.2%
75
  70.8%
Time Frame 1 week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Experimental
Hide Arm/Group Description

Metoclopramide 10mg IV+ dexamethasone 10mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

Dexamethasone: dexamethasone 10mg intramuscular injection

Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM

metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes

methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection

All-Cause Mortality
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)      0/111 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Experimental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/109 (0.00%)      0/111 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Experimental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/109 (2.75%)      16/111 (14.41%)    
Nervous system disorders     
Akathisia *  2/109 (1.83%)  2 7/111 (6.31%)  7
Skin and subcutaneous tissue disorders     
Injection site reaction *  1/109 (0.92%)  1 9/111 (8.11%)  9
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin W. Friedman, MD
Organization: Montefiore Health
Phone: 17189206626
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02847494     History of Changes
Other Study ID Numbers: 2016-6342
First Submitted: July 25, 2016
First Posted: July 28, 2016
Results First Submitted: December 18, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019