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Dexamethasone for Post Traumatic Headache

Primary Purpose

Post-Traumatic Headache

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Metoclopramide 10mg
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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 allergies or contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

Sites / Locations

  • MontefioreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Dexamethasone 10mg IV + metoclopramide 10mg IV

Placebo IV + metoclopramide 10mg IV

Outcomes

Primary Outcome Measures

Moderate or Severe headache after Emergency Department discharge
Rating headache moderate or severe on a scale of severe, moderate, mild, or none

Secondary Outcome Measures

Sustained headache relief
Achieving a headache intensity of mild or none in the emergency department without use of rescue medication and maintaining that level for 48 hours without use of rescue medication.
Post concussive symptom scale
The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). On this validated instrument, patients rate 22 concussive symptoms on a 0 to 6 scale, with 6 signifying more severe pain

Full Information

First Posted
March 11, 2021
Last Updated
February 21, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04799015
Brief Title
Dexamethasone for Post Traumatic Headache
Official Title
A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 10mg IV + metoclopramide 10mg IV
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IV + metoclopramide 10mg IV
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 10mg IV
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10mg
Intervention Description
Metoclopramide 10mg IV
Primary Outcome Measure Information:
Title
Moderate or Severe headache after Emergency Department discharge
Description
Rating headache moderate or severe on a scale of severe, moderate, mild, or none
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Sustained headache relief
Description
Achieving a headache intensity of mild or none in the emergency department without use of rescue medication and maintaining that level for 48 hours without use of rescue medication.
Time Frame
48 hours
Title
Post concussive symptom scale
Description
The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). On this validated instrument, patients rate 22 concussive symptoms on a 0 to 6 scale, with 6 signifying more severe pain
Time Frame
48 hours and 7 days after emergency department discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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 allergies or contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Friedman, MD
Phone
718-920-6626
Email
befriedm@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Phone
718-920-6626
Email
befriedm@montefiore.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexamethasone for Post Traumatic Headache

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