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Which IV drug eases concussion symptoms best? new trial aims to find out

NCT ID NCT07634393

Symptom relief Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two intravenous medications—metoclopramide and acetaminophen—to see which one better relieves acute concussion symptoms like headache, dizziness, and nausea in emergency room patients. Researchers will enroll 200 adults with mild head injuries and track their symptoms over a week. The goal is to provide clearer guidance on which drug works best for post-concussion care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metoclopramide and acetaminophen
What this could lead to
If it works, this could point toward a better standard treatment for concussion symptoms in the emergency room.
What could go wrong
This is a small, early-phase trial with only 200 participants, so results may not apply to everyone. Both drugs are already used, so no major new risks are expected, but the study may not find a clear winner.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults presenting to one of the study emergency departments (EDs) * Acute minor traumatic brain injury/concussion as defined by the Zurich Consensus Statement, including symptoms in somatic, cognitive, emotional, behavioral, physical, cognitive impairment, or sleep domains * ED visit occurring within 7 days of the head injury * Overall pain intensity greater than \>=6 on a 0-10 scale * Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10 * Reported post-concussion symptoms were not present prior to the injury * Treating attending physician plans to administer a parenteral medication Exclusion Criteria: * Already treated with an anti-dopaminergic medication for post-concussion symptoms * Contraindications to study medications, including: * Pheochromocytoma * Seizure disorder * Parkinson's disease * Use of monoamine oxidase (MAO) inhibitors * Use of anti-rejection transplant medications * Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.

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Conditions

The condition(s) this trial relates to.

Brain Concussion Craniocerebral Trauma head injury Post-Concussion Syndrome traumatic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Concussion post syndrome Head trauma injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Montefiore Medical Center

    New York, New York, 10467, United States

More trials for these conditions

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