Dexamethasone for Post Traumatic Headache

Sponsor

Montefiore Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04799015

Collaborator

(none)

162

Enrollment

Location

Arms

35.2

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Headache	Drug: Dexamethasone Drug: Metoclopramide 10mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache

Actual Study Start Date :

Feb 24, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Dexamethasone 10mg IV + metoclopramide 10mg IV	Drug: Dexamethasone Dexamethasone 10mg IV Drug: Metoclopramide 10mg Metoclopramide 10mg IV
Placebo Comparator: Placebo Placebo IV + metoclopramide 10mg IV	Drug: Metoclopramide 10mg Metoclopramide 10mg IV

Arm

Intervention/Treatment

Experimental: Dexamethasone

Dexamethasone 10mg IV + metoclopramide 10mg IV

Drug: Dexamethasone

Dexamethasone 10mg IV

Drug: Metoclopramide 10mg

Metoclopramide 10mg IV

Placebo Comparator: Placebo

Placebo IV + metoclopramide 10mg IV

Drug: Metoclopramide 10mg

Metoclopramide 10mg IV

Outcome Measures

Primary Outcome Measures

Moderate or Severe headache after Emergency Department discharge [48 hours]
Rating headache moderate or severe on a scale of severe, moderate, mild, or none

Secondary Outcome Measures

Sustained headache relief [48 hours]
Achieving a headache intensity of mild or none in the emergency department without use of rescue medication and maintaining that level for 48 hours without use of rescue medication.
Post concussive symptom scale [48 hours and 7 days after emergency department discharge]
The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). On this validated instrument, patients rate 22 concussive symptoms on a 0 to 6 scale, with 6 signifying more severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, 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 allergies or contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore	Bronx	New York	United States	10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT04799015

Other Study ID Numbers:

2020-12625

First Posted:

Mar 16, 2021

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Post-Traumatic Headache

Headache

Dexamethasone

Metoclopramide

Study Results

No Results Posted as of Feb 17, 2022