drugset / Trial / NCT03220958

Metoclopramide for Post Traumatic Headache

NCT03220958 ↗

Phase 3 Completed 160 enrolled Montefiore Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-08-01
Primary completion
2020-04-01
Completion
2020-04-01

Outcome

Met primary endpoint

paper Patients receiving placebo reported mean improvement of 3.8 (SD 2.6), while those receiving M + D improved by 5.2 (SD 2.3), for a difference favoring metoclopramide of 1.4 (95% confidence interval [CI] 0.7-2.2, p < 0.01). PMID 33762421 ↗

paper CONCLUSION: M + D was more efficacious than placebo with regard to relief of posttraumatic headache in the ED. PMID 33762421 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metoclopramide Small molecule 20 mg Intravenous
Background Diphenhydramine Small molecule 25 mg Intravenous