NCT03220958

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 9, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

April 19, 2017

Results QC Date

July 13, 2021

Last Update Submit

November 8, 2021

Conditions

Post-Traumatic Headache

Outcome Measures

Primary Outcomes (1)

  • 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable

    Improvement in this 0 to 10 verbal rating scale

    1 hour after medication administration

Secondary Outcomes (2)

  • Sustained Headache Relief

    48 hours after medication administration

  • Headache Days

    7 days after ED visit

Study Arms (2)

Metoclopramide

EXPERIMENTAL

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

Drug: MetoclopramideDrug: DiphenhydramineDrug: Normal saline

Placebo

PLACEBO COMPARATOR

Normal saline, administered as an intravenous drip

Drug: Normal saline

Interventions

MetoclopramideDRUG

Metoclopramide 20mg

Metoclopramide
DiphenhydramineDRUG

Diphenhydramine 25mg

Metoclopramide
Normal salineDRUG

100ml normal saline

MetoclopramidePlacebo

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • 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.

    PMID: 33762421DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

MetoclopramideDiphenhydramineSaline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsEthylaminesAminesBenzhydryl CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Benjamin Friedman
Organization
Montefiore
befriedm@montefiore.org
718-920-6626

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2017

First Posted

July 18, 2017

Study Start

August 1, 2017

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

November 9, 2021

Results First Posted

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)