What side effects are associated with this type of intervention?

Dexamethasone, a corticosteroid used to reduce inflammation and immune responses, can have several side effects. Common side effects include increased blood sugar levels, weight gain, fluid retention, hypertension, and mood changes. Long-term use can lead to more serious complications such as osteoporosis, gastrointestinal bleeding, and increased risk of infections. In the context of post-traumatic headache, these side effects need to be carefully weighed against the potential benefits, and treatment should be closely monitored by a healthcare provider.

What prior FDA approvals exist?

While specific FDA approvals for the treatment of post-traumatic headache using dexamethasone are not detailed, corticosteroids like dexamethasone are generally approved for their anti-inflammatory and immunosuppressive properties. These drugs are commonly used to reduce inflammation and manage pain in various conditions, including headaches resulting from trauma. Other treatments for post-traumatic headache may include nonsteroidal anti-inflammatory drugs (NSAIDs) and other pain management strategies, but the use of corticosteroids remains a key approach due to their effectiveness in reducing inflammation and associated symptoms.

What other types of research exist?

Promising novel alternatives to dexamethasone for post-traumatic headache patients include intravenous metoclopramide, which has been studied in combination with dexamethasone and shown efficacy in acute PTH management. Additionally, emerging treatments such as CGRP (calcitonin gene-related peptide) inhibitors, which are being explored for various headache disorders, may offer potential benefits. Consultation with a healthcare provider is essential to determine the most appropriate treatment based on individual patient needs and the latest clinical evidence.

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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after ed discharge

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares two treatments for headaches after a head injury. One treatment uses two medicines (metoclopramide and dexamethasone), while the other uses just one (metoclopramide). The goal is to see which treatment works better for people who have headaches following a head injury. Metoclopramide is commonly used to reduce nausea and vomiting associated with migraines, and dexamethasone is often used for its anti-inflammatory effects.

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.

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.

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 ~ up to 48 hours after ed discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 hours after ed discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours after ed discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency Moderate or Severe headache after Emergency Department (ED) discharge

Secondary study objectives

Post concussive symptoms

Sustained headache relief

Use of Rescue medication

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

~2650

Metoclopramide 10mg

2019

Completed Phase 4

~550

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Corticosteroids, such as dexamethasone, are commonly used in the treatment of Post-Traumatic Headache (PTH) due to their potent anti-inflammatory and immunosuppressive properties. These medications work by reducing inflammation and modulating the immune response, which helps to alleviate pain and other symptoms associated with PTH. This mechanism is particularly important for PTH patients as it addresses the underlying inflammation that contributes to their pain and discomfort, potentially leading to quicker and more effective symptom relief and recovery.