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Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

Study acronym: IMPACT
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 30, 2028 → Oct 2028
See other at-risk trials from Montefiore Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Aug 1, 2026 to Oct 2026 Show 7 more changesShow less
    • Primary completion pushed from Jun 30, 2028 to Oct 2028
    • Study completion pushed from Aug 4, 2028 to Oct 2028
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 11 words
    • Site contact updated
    • Publications: details revised at 8 of 9 entries
  2. Secondary endpoints: details revised at 1 of 1 entryv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07634393
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Concussion Post Syndrome, Head Trauma Injury
Related terms Brain Concussion, Craniocerebral Trauma, Post-Concussion Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov