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Phase 3 Completed N=160 Randomized Quadruple-blind Treatment

Metoclopramide for Post Traumatic Headache

Post-Traumatic Headache
Source: ClinicalTrials.gov NCT03220958 ↗
Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable — 5.2; 3.8 units on a scale
◆ Published Evidence
Emerging
14citations · ~3 / year
Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache.
Neurology · 2021 · Open access · Likely link

Summary

Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.

Linked Publications

  • Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache.
    Neurology · 2021 · 14 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
5.2; 3.8
SECONDARY
Sustained Headache Relief
24; 18
SECONDARY
Headache Days
3.3; 3.3

Eligibility Criteria

Inclusion Criteria

Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:

  • Traumatic injury to the head has occurred
  • Headache has developed within 7 days of injury to the head
  • Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)

The headache must be rated as moderate or severe in intensity at the time of initial evaluation.

Exclusion Criteria

Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03220958) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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