← Back to Search

Corticosteroid

Dexamethasone + Metoclopramide for Post-Traumatic Headache

Phase 4

Recruiting

Led By Benjamin Friedman, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours and 7 days after emergency department discharge

Awards & highlights

Study Summary

This trial is testing whether adding dexamethasone to metoclopramide improves headaches after head trauma.

Who is the study for?

This trial is for adults with a moderate or severe headache that started within 7 days of a head injury, fitting the criteria for acute post-traumatic headache. It's not suitable for those whose headaches have been treated with anti-dopaminergic meds, or who have certain conditions like pheochromocytoma, seizures, Parkinson's disease, or use MAO inhibitors/transplant drugs.Check my eligibility

What is being tested?

The study is testing if adding dexamethasone to metoclopramide treatment is more effective than metoclopramide alone in treating acute post-traumatic headaches. Participants are randomly assigned to one of these two treatments.See study design

What are the potential side effects?

Possible side effects include stomach upset and fatigue from metoclopramide and increased appetite, mood changes, insomnia and potential increase in blood sugar levels from dexamethasone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours and 7 days after emergency department discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours and 7 days after emergency department discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours and 7 days after emergency department discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Moderate or Severe headache after Emergency Department discharge

Secondary outcome measures

Post concussive symptom scale

Sustained headache relief

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DexamethasoneExperimental Treatment2 Interventions

Dexamethasone 10mg IV + metoclopramide 10mg IV

Group II: PlaceboPlacebo Group1 Intervention

Placebo IV + metoclopramide 10mg IV

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Metoclopramide 10mg

2019

Completed Phase 4

~680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

443 Previous Clinical Trials

582,374 Total Patients Enrolled

2 Trials studying Post-Traumatic Headache

181 Patients Enrolled for Post-Traumatic Headache

Benjamin Friedman, MDPrincipal InvestigatorMontefiore Medical Center

6 Previous Clinical Trials

1,680 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04799015 — Phase 4

Post-Traumatic Headache Research Study Groups: Dexamethasone, Placebo

Post-Traumatic Headache Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT04799015 — Phase 4

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04799015 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What applications does Dexamethasone possess for medicinal purposes?

"Ophthalmia, sympathetic is frequently managed with the anti-inflammatory steroid Dexamethasone. Additional afflictions that may benefit from this medication include branch retinal vein occlusion, gastroparesis, and macular edema."

Answered by AI

Can you provide a listing of the past experiments concerning Dexamethasone?

"Presently, 560 clinical trials are underway related to the use of Dexamethasone. 145 of these trials are in their third phase, and there is an immense number (18660) of trial sites across Mishawaka, Indiana."

Answered by AI

What risks should be considered when administering Dexamethasone to patients?

"There is ample evidence supporting the safety of Dexamethasone, thus its score on our 1-3 scale was 3. This reflects its status as an approved treatment in Phase 4 trials."

Answered by AI

Are there opportunities for new participants to join this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this experiment is actively seeking individuals for participation. It was first posted on February 24th 2021, and last updated sixteen days ago in the month of February 2022; 162 participants are being recruited from a solitary site."

Answered by AI

How many individuals have been recruited for participation in this clinical experiment?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is currently recruiting individuals, after being initially posted on February 24th 2021 and modified as recently as February 16th 2022. 162 participants are needed from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dexamethasone for Post Traumatic Headache

2021. "Dexamethasone for Post Traumatic Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04799015.

All > Headache