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Metoclopramide vs Acetaminophen for Concussion

(IMPACT Trial)

HS
BW
Overseen ByBenjamin W W.Friedman, MD,MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Montefiore Medical Center
Must not be taking: Anti-dopaminergics, MAO inhibitors
Disqualifiers: Pheochromocytoma, Seizure disorder, Parkinson's, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The IMPACT study is a randomized, double-blind clinical trial evaluating two commonly used intravenous medications - metoclopramide and acetaminophen - for treating acute post-concussion symptoms in emergency department patients after mild head injury. The study aims to determine which treatment more effectively improves symptoms such as headache, dizziness, nausea, concentration difficulties, and emotional changes within the first week after injury.

Participants will be enrolled across two Montefiore emergency departments and followed using a validated post-concussion symptom questionnaire. Findings from this study may help improve evidence-based treatment strategies for patients experiencing concussion-related symptoms after head trauma.

Who Is on the Research Team?

BW

Benjamin W Friedman, MD,MS

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who come to the emergency room within 7 days of a mild head injury and are experiencing new, significant post-concussion symptoms like headache or dizziness. They must have moderate-to-severe pain and their doctor plans to give them medication through an IV.

Inclusion Criteria

Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
I went to the emergency room within 7 days of my head injury.
My pain level is 6 or higher on a scale from 0 to 10.
See 4 more

Exclusion Criteria

I do not have any conditions that prevent me from taking the study medications.
I do not have any reasons that prevent me from taking the study medications.
I cannot take the study drugs or MAO inhibitors.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intravenous metoclopramide or acetaminophen for acute post-concussion symptoms

Immediate (single dose)
1 visit (in-person)

Follow-up

Participants are monitored for changes in post-concussion symptoms using the RPQ and NRS pain score

7 days
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Metoclopramide

Trial Overview

The study compares two IV medications—metoclopramide (10mg) versus acetaminophen—to see which works better at relieving acute concussion symptoms such as headache, nausea, and trouble concentrating in the first week after injury. Participants are randomly assigned to one treatment group.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Metoclopramide 10 mgActive Control1 Intervention
Group II: AcetaminophenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

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