At a glance
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A Randomized, Placebo-Controlled, Double-Blind Study of the Effects of Magnesium Compared to Conventional Therapy on Acute Migraine
In Brief
A Phase 3 clinical trial evaluating Magnesium Sulfate, Metoclopramide 10mg, and 1 other intervention for Migraine and Headache. Completed, enrolled 157 participants across 1 site.
Detailed 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 None of these study agents have been withdrawn from the market.
Study Details
Timeline
Interventions
Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
Metoclopramide 10mg in 50ml D5W over 20 minutes
Prochlorperazine 10mg in 50ml D5W over 20 minutes