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Diphenhydramine for Acute Migraine

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ClinicalTrials.gov Identifier: NCT01825941
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : June 8, 2018
Last Update Posted : July 31, 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: metoclopramide
Drug: diphenhydramine
Drug: placebo
Enrollment 208
Recruitment Details Protocol anticipated enrollment of around 400 participants, however Data Safety Monitoring Board recommended enrollment cut to approximately half
Pre-assignment Details  
Arm/Group Title Metoclopramide + Diphenhydramine Metoclopramide + Placebo
Hide Arm/Group Description

Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

diphenhydramine: 50 milligrams, administered intravenously over 15 minutes

Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

placebo

Period Title: Overall Study
Started 104 104
Completed 100 103
Not Completed 4 1
Reason Not Completed
Lost to Follow-up             4             1
Arm/Group Title Metoclopramide + Diphenhydramine Metoclopramide + Placebo Total
Hide Arm/Group Description

Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

diphenhydramine: 50 milligrams, administered intravenously over 15 minutes

Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

placebo

Total of all reporting groups
Overall Number of Baseline Participants 104 104 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 104 participants 208 participants
34  (11) 36  (10) 35  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 208 participants
Female
88
  84.6%
92
  88.5%
180
  86.5%
Male
16
  15.4%
12
  11.5%
28
  13.5%
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 104 participants 104 participants 208 participants
104
 100.0%
104
 100.0%
208
 100.0%
Duration of headache Prior to Study  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 104 participants 104 participants 208 participants
72
(24 to 96)
48
(16 to 72)
48
(24 to 96)
1.Primary Outcome
Title Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Hide Description Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department
Time Frame up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metoclopramide + Diphenhydramine Metoclopramide + Placebo
Hide Arm/Group Description:

Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

diphenhydramine: 50 milligrams, administered intravenously over 15 minutes

Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

placebo

Overall Number of Participants Analyzed 100 103
Measure Type: Count of Participants
Unit of Measure: Participants
40
  40.0%
38
  36.9%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metoclopramide + Diphenhydramine Metoclopramide + Placebo
Hide Arm/Group Description

Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

diphenhydramine: 50 milligrams, administered intravenously over 15 minutes

Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

metoclopramide: 10 milligrams, administered intravenously over 15 minutes

placebo

All-Cause Mortality
Metoclopramide + Diphenhydramine Metoclopramide + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)      0/104 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Metoclopramide + Diphenhydramine Metoclopramide + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/103 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metoclopramide + Diphenhydramine Metoclopramide + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/104 (24.04%)      21/104 (20.19%)    
Nervous system disorders     
Restlessness *  8/104 (7.69%)  8 7/104 (6.73%)  7
Drowsy *  17/104 (16.35%)  17 14/104 (13.46%)  14
*
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, MS
Organization: Montefiore Medical Center
Phone: 718-920-6266
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01825941     History of Changes
Other Study ID Numbers: 13-02-071
First Submitted: April 2, 2013
First Posted: April 8, 2013
Results First Submitted: May 7, 2018
Results First Posted: June 8, 2018
Last Update Posted: July 31, 2018