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Metoclopramide for Post-Traumatic Headache. A Pilot Study

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. Read our disclaimer for details. Identifier: NCT03056352
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, 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 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
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
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : August 15, 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. Number of Participants With Sustained Headache Relief [ Time Frame: 2 hours thru 48 hours after treatment ]
    Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.

Secondary Outcome Measures :
  1. Post Concussion Symptoms Assessed by Post-concussive Symptom Scale [ Time Frame: 7 days ]
    The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.

  2. Number of Participants Satisfied With Medication; Assessed by Self-evaluation [ Time Frame: 48 hours after treatment ]
    Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 monoamine oxidase 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 identifier (NCT number): NCT03056352

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
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Responsible Party: Benjamin W. Friedman, MD, Professor, Montefiore Medical Center Identifier: NCT03056352    
Other Study ID Numbers: 2017-7511
First Posted: February 17, 2017    Key Record Dates
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Post-Traumatic Headache
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
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
Anti-Allergic Agents