A Randomized, Placebo-Controlled, Double-Blind Study of the Effects of Magnesium Compared to Conventional Therapy on Acute Migraine

AHC-7192-D5000322

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 None of these study agents have been withdrawn from the market.

2019-08-23

2020-03-31

2023-04-06

Completed

Early phase I

288

Inclusion Criteria: * Age \> 18 years or older * Able to provide informed consent * Primary diagnosis of headache or migraine * Between October 1, 2018 to April 1, 2020 * Presenting to Advocate Christ Medical Center emergency department and meet clinical assessment per physician Exclusion Criteria: * Pregnancy defined as a positive urine HCG * Stated history of renal impairment * Allergy or sensitivity to any study drugs * Concomitant treatment at the time of study drug administered in the emergency department * Patients with a history of this study participation

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2023-08-01