Back to resultsMetoclopramide for Post Traumatic Headache
Primary Purpose
Post-Traumatic Headache
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Metoclopramide
Diphenhydramine
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Headache
Eligibility Criteria
Inclusion Criteria:
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:
- Traumatic injury to the head has occurred
- Headache has developed within 7 days of injury to the head
- Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
Exclusion Criteria:
Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metoclopramide
Placebo
Arm Description
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Normal saline, administered as an intravenous drip
Outcomes
Primary Outcome Measures
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
Improvement in this 0 to 10 verbal rating scale
Secondary Outcome Measures
Sustained Headache Relief
Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe
Headache Days
Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities
Full Information
NCT ID
NCT03220958
First Posted
April 19, 2017
Last Updated
November 8, 2021
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03220958
Brief Title
Metoclopramide for Post Traumatic Headache
Official Title
A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metoclopramide
Arm Type
Experimental
Arm Description
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline, administered as an intravenous drip
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
Metoclopramide 20mg
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
Diphenhydramine 25mg
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
100ml normal saline
Primary Outcome Measure Information:
Title
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
Description
Improvement in this 0 to 10 verbal rating scale
Time Frame
1 hour after medication administration
Secondary Outcome Measure Information:
Title
Sustained Headache Relief
Description
Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe
Time Frame
48 hours after medication administration
Title
Headache Days
Description
Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities
Time Frame
7 days after ED visit
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:
Traumatic injury to the head has occurred
Headache has developed within 7 days of injury to the head
Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
Exclusion Criteria:
Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33762421
Citation
Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.
Results Reference
derived
Learn more about this trial
Metoclopramide for Post Traumatic Headache
We'll reach out to this number within 24 hrs