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NCT07634393 · ClinicalTrials.gov registry record · Phase 4
Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
A Phase 4 study, sponsored by Montefiore Medical Center.
- Not yet
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT07634393: Clinical Trial Phase 4 study, sponsored by Montefiore Medical Center.
NCT07634393 is a Phase 4 study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07634393, a Phase 4 study, has not yet begun recruiting, sponsored by Montefiore Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Change in post-concussion symptoms from baseline to 48 hours after treatment will be measured using the RPQ. The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury. It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") t
Interventions
- DRUG Acetaminophen
- DRUG Metoclopramide 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2028-08-04 |
| Phase | Phase 4 |
What is known before NCT07634393 opens enrollment
NCT07634393 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT07634393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07634393 about?
NCT07634393 is a clinical study titled "Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment". 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 mor...
What is the current status of trial NCT07634393?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2026-08-01. Estimated completion is 2028-08-04.
What interventions are being tested in trial NCT07634393?
The interventions under investigation include: Acetaminophen (DRUG), Metoclopramide 10mg (DRUG).
Who is sponsoring clinical trial NCT07634393?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07634393's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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