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Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines

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ClinicalTrials.gov Identifier: NCT00122278
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
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: Treatment
Condition Migraine
Interventions Drug: Dexamethasone
Other: Placebo
Enrollment 205
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description

Dexamethasone 10 mg

Dexamethasone: Dexamethasone 10mg IV

Placebo Dexamethasone, 10 mg

Placebo: Placebo Dexamethasone 10mg IV

Period Title: Overall Study
Started 106 99
Completed 104 99
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Arm/Group Title Dexamethasone Placebo Total
Hide Arm/Group Description

Dexamethasone 10 mg

Dexamethasone: Dexamethasone 10mg IV

Placebo Dexamethasone, 10 mg

Placebo: Placebo Dexamethasone 10mg IV

Total of all reporting groups
Overall Number of Baseline Participants 106 99 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 99 participants 205 participants
36  (10) 37  (11) 37  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 99 participants 205 participants
Female
87
  82.1%
87
  87.9%
174
  84.9%
Male
19
  17.9%
12
  12.1%
31
  15.1%
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 106 participants 99 participants 205 participants
106
 100.0%
99
 100.0%
205
 100.0%
Duration of headache Prior to Study  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 106 participants 99 participants 205 participants
48
(19 to 72)
48
(12 to 72)
48
(12 to 72)
1.Primary Outcome
Title Persistent Headache Pain Free at 24 Hours
Hide Description Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 10 mg

Dexamethasone: Dexamethasone 10mg IV

Placebo Dexamethasone, 10 mg

Placebo: Placebo Dexamethasone 10mg IV

Overall Number of Participants Analyzed 104 99
Measure Type: Count of Participants
Unit of Measure: Participants
26
  25.0%
19
  19.2%
2.Secondary Outcome
Title Functional Disability at 24 Hours
Hide Description No functional impairment within 24 hours of emergency department discharge
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description:

Dexamethasone 10 mg

Dexamethasone: Dexamethasone 10mg IV

Placebo Dexamethasone, 10 mg

Placebo: Placebo Dexamethasone 10mg IV

Overall Number of Participants Analyzed 104 99
Measure Type: Count of Participants
Unit of Measure: Participants
70
  67.3%
55
  55.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone Placebo
Hide Arm/Group Description

Dexamethasone 10 mg

Dexamethasone: Dexamethasone 10mg IV

Placebo Dexamethasone, 10 mg

Placebo: Placebo Dexamethasone 10mg IV

All-Cause Mortality
Dexamethasone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)      0/99 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/106 (0.00%)      0/99 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dexamethasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/106 (38.68%)      27/99 (27.27%)    
General disorders     
Dizziness   3/106 (2.83%)  3 2/99 (2.02%)  2
Acute Medication Reactoin   10/106 (9.43%)  10 2/99 (2.02%)  2
Other   9/106 (8.49%)  9 12/99 (12.12%)  12
Nervous system disorders     
Drowsiness   19/106 (17.92%)  19 11/99 (11.11%)  11
Indicates events were collected by 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, MS
Organization: Montefiore Medical Center
Phone: (718)920-6266
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00122278     History of Changes
Other Study ID Numbers: 05-02-032S
First Submitted: July 20, 2005
First Posted: July 22, 2005
Results First Submitted: April 18, 2018
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018