Phase 3 N=160 Randomized Quadruple-blind Treatment

Metoclopramide for Post Traumatic Headache

Post-Traumatic Headache

Bottom Line

View on ClinicalTrials.gov: NCT03220958 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable — 5.2; 3.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Metoclopramide (Drug); Diphenhydramine (Drug); Normal saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-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	—

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.

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). 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.