drugset / Trial / NCT05967442

Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines

NCT05967442

Phase 3 Completed 157 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This investigation describes a proposed clinical trial that will evaluate the relative efficacy of intravenous magnesium sulfate for the treatment of migraine compared to intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the treatment of acute headache and migraine in adult patients. The ultimate objective will be clinical application of these drugs in the emergency department for the treatment of acute headache and migraine. The two phenothiazines (metoclopramide and prochlorperazine) have been routinely utilized in the treatment of acute headache and migraine in the emergency department setting. Per the 2017 American Headache Society guidelines, both intravenous metoclopramide and intravenous procholorperazine are recommended as "clinicians should offer" agents with level B evidence. Of note, there are no agents with level A evidence purported by this guideline for acute management of migraine. The same guideline offers "no recommendation can be made regarding the role of intravenous magnesium for adults who present to the ED with acute migraine. However intravenous magnesium may be of benefit to patients who present with migraine with aura." Multiple trials have evaluated intravenous magnesium's safety and efficacy in the management of acute migraine. These have demonstrated the tolerability of intravenous magnesium on a with breadth of patients. Most commonly the primary adverse event was flushing which self-resolved. No cases of hypotension were reported. None of these study agents have been withdrawn from the market.

Timeline

Start
2019-08-23
Primary completion
2020-03-31
Completion
2023-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 2 g Intravenous
Comparator Metoclopramide Small molecule 10 mg Intravenous
Comparator Prochlorperazine Small molecule 10 mg Intravenous

Indications