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Metoclopramide for Post Traumatic Headache

NCT ID: NCT03220958

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-04-01

Brief Summary

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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.

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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Metoclopramide

Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip

Group Type EXPERIMENTAL

Metoclopramide

Intervention Type DRUG

Metoclopramide 20mg

Diphenhydramine

Intervention Type DRUG

Diphenhydramine 25mg

Normal saline

Intervention Type DRUG

100ml normal saline

Placebo

Normal saline, administered as an intravenous drip

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

100ml normal saline

Interventions

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Metoclopramide

Metoclopramide 20mg

Intervention Type DRUG

Diphenhydramine

Diphenhydramine 25mg

Intervention Type DRUG

Normal saline

100ml normal saline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 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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Benjamin W. Friedman, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33762421 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017-7898

Identifier Type: -

Identifier Source: org_study_id