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Treatment of Acute Migraine Headache in Children

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ClinicalTrials.gov Identifier: NCT00355394
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : August 30, 2013
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migrainous Headache
Interventions Drug: Metoclopramide
Other: Placebo
Enrollment 31
Recruitment Details Subjects recruited from tertiary care emergency department (ED). N=31.
Pre-assignment Details  
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description Placebo group received standard care including IVF but not metoclopramide. Metoclopramide group received standard care including IVF and also IV metoclopramide.
Period Title: Overall Study
Started 15 16
Completed 15 16
Not Completed 0 0
Arm/Group Title Placebo Metoclopramide Total
Hide Arm/Group Description Placebo group received standard care including IVF but not metoclopramide. Metoclopramide group received standard care including IVF AND metoclopramide. Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
<=18 years
15
 100.0%
16
 100.0%
31
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
10.8  (3.1) 12.9  (2.4) 11.9  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
9
  60.0%
8
  50.0%
17
  54.8%
Male
6
  40.0%
8
  50.0%
14
  45.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15 16 31
1.Primary Outcome
Title The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.
Hide Description The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All participants included.
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description:
Placebo
Metoclopramide
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: participants
5 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Metoclopramide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title The Number of Subjects With a NRS Score of Zero at One Hour.
Hide Description The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
All participants included.
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description:
Placebo
Metoclopramide
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: participants
1 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Metoclopramide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title The Number of Subjects With a NRS Score of Zero at 24 Hours.
Hide Description The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description:
Placebo group received standard care including IVF but not metoclopramide.
Metoclopramide group received standard care including IVF and also IV metoclopramide.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: participants
4 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Metoclopramide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.
Hide Description The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Time Frame 1 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All participants included.
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description:
Placebo group received standard care including IVF but not metoclopramide.
Metoclopramide group received standard care including IVF and also IV metoclopramide.
Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: NRS Score
-2.5  (2.5) -6.8  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Metoclopramide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.
Hide Description The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description:
Placebo group received standard care including IVF but not metoclopramide.
Metoclopramide group received standard care including IVF and also IV metoclopramide.
Overall Number of Participants Analyzed 15 16
Median (Standard Deviation)
Unit of Measure: NRS Score
-4.9  (2.8) -7.8  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Metoclopramide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.
Hide Description The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description:
Placebo group received standard care including IVF but not metoclopramide.
Metoclopramide group received standard care including IVF and also IV metoclopramide.
Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: NRS Score
-4.5  (2.9) -5.6  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Metoclopramide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Metoclopramide
Hide Arm/Group Description Placebo group received standard care including IVF but not metoclopramide. Metoclopramide group received standard care including IVF and also IV metoclopramide.
All-Cause Mortality
Placebo Metoclopramide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Metoclopramide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Metoclopramide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Study was performed in tertiary care setting and may not be generalizable to all settings. Small number of subjects (n=31). None admitted or received additional rescue medication, suggesting most severely affected may not have been enrolled.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Nicholas Abend
Organization: CHOP
Phone: 215-590-1719
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00355394     History of Changes
Other Study ID Numbers: 2006-4-4755
First Submitted: July 19, 2006
First Posted: July 21, 2006
Results First Submitted: January 8, 2013
Results First Posted: August 30, 2013
Last Update Posted: November 30, 2015