CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 157 enrolled
Drug / intervention
Magnesium Sulfate +2 moredrug
Likely dose
Metoclopramide 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05967442
NCT05967442Phase 3Completed

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

Wake Forest University Health Sciences·interventional·Posted Aug 1, 2023·Updated Oct 8, 2024

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 None of these study agents have been withdrawn from the market.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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine, Headache
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 1, 2023
Enrollment StartAug 23, 2019
Primary CompletionMar 31, 2020
Study CompletionApr 6, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.9 years ago

Interventions

Magnesium Sulfatedrug

Magnesium Sulfate 2gm in 50ml D5W over 20 minutes

Metoclopramide 10mgdrug

Metoclopramide 10mg in 50ml D5W over 20 minutes

Prochlorperazine (Compazine) Injectiondrug

Prochlorperazine 10mg in 50ml D5W over 20 minutes