Dexamethasone for Post Traumatic Headache

NCT ID: NCT04799015

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2024-12-22

Brief Summary

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

Detailed Description

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Conditions

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Post-Traumatic Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

Dexamethasone 10mg IV + metoclopramide 10mg IV

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 10mg IV

Metoclopramide 10mg

Intervention Type DRUG

Metoclopramide 10mg IV

Placebo

Placebo IV + metoclopramide 10mg IV

Group Type PLACEBO_COMPARATOR

Metoclopramide 10mg

Intervention Type DRUG

Metoclopramide 10mg IV

Interventions

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Dexamethasone

Dexamethasone 10mg IV

Intervention Type DRUG

Metoclopramide 10mg

Metoclopramide 10mg IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Meet International Classification of Headache Disorders criteria for acute post-traumatic headache 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 (e.g., migraine or tension-type headache)
* The headache must be rated as moderate or severe in intensity at the time of initial evaluation

Exclusion Criteria

* More than ten days have elapsed since the head trauma
* Headache has already been treated with an anti-dopaminergic medication
* Medication allergies
* Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2020-12625

Identifier Type: -

Identifier Source: org_study_id

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