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Metoclopramide for Migraine: A Dose Finding Study (MDFS)

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ClinicalTrials.gov Identifier: NCT00682734
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : December 31, 2012
Last Update Posted : May 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 25mg
Enrollment 349
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Intravenous Metoclopramide 40 mg Intravenous
Hide Arm/Group Description Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
Period Title: Emergency Department Portion
Started 113 118 118
Completed 113 117 117
Not Completed 0 1 1
Period Title: 48 Hour Follow-up
Started 113 117 117
Completed 107 111 106
Not Completed 6 6 11
Arm/Group Title Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Metoclopramide 40 mg Total
Hide Arm/Group Description Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous Total of all reporting groups
Overall Number of Baseline Participants 113 118 118 349
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Adults Number Analyzed 113 participants 118 participants 118 participants 349 participants
38.7  (11.5) 37.5  (9.9) 38.4  (12.0) 38.2  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 118 participants 118 participants 349 participants
Female
94
  83.2%
103
  87.3%
97
  82.2%
294
  84.2%
Male
19
  16.8%
15
  12.7%
21
  17.8%
55
  15.8%
1.Primary Outcome
Title Pain Intensity Score
Hide Description Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.
Time Frame Baseline, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Metoclopramide 40 mg
Hide Arm/Group Description:
Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous
Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
Overall Number of Participants Analyzed 113 117 117
Mean (Standard Deviation)
Unit of Measure: scores on a scale
4.7  (2.6) 4.9  (2.8) 5.3  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Metoclopramide 40 mg
Hide Arm/Group Description Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
All-Cause Mortality
Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Metoclopramide 40 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Metoclopramide 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/113 (0.00%)      1/118 (0.85%)      0/118 (0.00%)    
Nervous system disorders       
Encephalitis  0/113 (0.00%)  0 1/118 (0.85%)  1 0/118 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
Metoclopramide 10 mg Intravenous Metoclopramide 20 mg Metoclopramide 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/113 (7.08%)      8/118 (6.78%)      7/118 (5.93%)    
Nervous system disorders       
Akathisia  8/113 (7.08%)  8/118 (6.78%)  7/118 (5.93%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin Friedman
Organization: Montefiore Medical Center
Phone: 718 920 6626
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00682734     History of Changes
Other Study ID Numbers: 07-11-405
First Submitted: May 19, 2008
First Posted: May 22, 2008
Results First Submitted: July 24, 2011
Results First Posted: December 31, 2012
Last Update Posted: May 31, 2018