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Metoclopramide for Post Traumatic Headache. An RCT

This study is currently recruiting participants.
Verified July 2017 by Benjamin Friedman, Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03220958
First Posted: July 18, 2017
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
  Purpose
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.

Condition Intervention Phase
Post-Traumatic Headache Drug: Metoclopramide Drug: Diphenhydramine Drug: Normal saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache

Resource links provided by NLM:


Further study details as provided by Benjamin Friedman, Montefiore Medical Center:

Primary Outcome Measures:
  • Numerical rating scale for pain [ Time Frame: 1 hour after medication administration ]
    Improvement in this 0 to 10 verbal rating scale


Secondary Outcome Measures:
  • Sustained headache relief [ Time Frame: 48 hours after medication administration ]
    Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none.

  • Headache days [ Time Frame: 7 days after ED visit ]
    Number of days with any headache

  • The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). [ Time Frame: 48 hours, 7 days, and 1 month ]
    On this validated instrument, patients rate 25 symptoms on a 0 to 6 scale.


Estimated Enrollment: 162
Anticipated Study Start Date: July 18, 2017
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
Drug: Metoclopramide
Metoclopramide 20mg
Drug: Diphenhydramine
Diphenhydramine 25mg
Drug: Normal saline
100ml normal saline
Placebo Comparator: Placebo
Normal saline, administered as an intravenous drip
Drug: Normal saline
100ml normal saline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220958


Locations
United States, New York
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Benjamin W Friedman, MD, MS    718-920-6626    befriedm@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Responsible Party: Benjamin Friedman, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03220958     History of Changes
Other Study ID Numbers: Metoclopramide for PTH. An RCT
First Submitted: April 19, 2017
First Posted: July 18, 2017
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Diphenhydramine
Metoclopramide
Promethazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics