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Metoclopramide for Post-Traumatic Headache. A Pilot Study

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ClinicalTrials.gov Identifier: NCT03056352
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center

Brief Summary:
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Drug: Metoclopramide Drug: Diphenhydramine Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metoclopramide for Post-Traumatic Headache. A Pilot Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
Drug: Metoclopramide
Intravenous medication drip
Other Name: Reglan
Drug: Diphenhydramine
Intravenous medication drip
Other Name: Benadryl

Primary Outcome Measures :
  1. Sustained headache relief [ Time Frame: 48 hours ]
    Headachelevel of mild or none achieved in the emergency department and maintained for 48 hours

Secondary Outcome Measures :
  1. Post concussion symptom scale [ Time Frame: 48 hours and 7 days ]
    This instrument assesses typical post-concussion symptoms

  2. Satisfaction with medication [ Time Frame: 48 hours ]
    Would you want to receive the same medication during a subsequent visit for post-traumatic headache?

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

Inclusion Criteria:

  • 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.
  • The plan of the attending emergency physician must include treatment with parenteral metoclopramide.

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. Patients will not be excluded for pregnancy or breast-feeding.

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): NCT03056352

Contact: Benjamin Friedman, MD, MS 7189206626 befriedm@montefiore.org

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

Responsible Party: Benjamin Friedman, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03056352     History of Changes
Other Study ID Numbers: 2017-7511
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 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.: No

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