Metoclopramide for Post Traumatic Headache

Post-Traumatic Headache Clinical Trial

Official title:

A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220958
• Other study ID #: 2017-7898
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2021
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

Drug:
• Metoclopramide
Metoclopramide 20mg
• Diphenhydramine
Diphenhydramine 25mg
• Normal saline
100ml normal saline

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	Improvement in this 0 to 10 verbal rating scale	1 hour after medication administration
Secondary	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	48 hours after medication administration
Secondary	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	7 days after ED visit