Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06904287

Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines

The purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Advocate Christ Medical Center Emergency Department

Oak Lawn, Illinois, 60453, United States

Location status: Recruiting

Location contact

Samar Ashrafi, PharmD

CONTACT

[email protected]

708-684-7895

About this study

The purpose of this prospective, randomized, double-blinded study is to compare the relative efficacy and safety of intravenous magnesium in conjunction with intravenous prochlorperazine in the treatment of migraines. Participants will be patients presenting to the Emergency Department with primary diagnosis of migraine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years or older
  • Able to provide informed consent
  • English speaking
  • Primary diagnosis of migraine. Patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), AND with a clinical exclusion of migraine mimics

Exclusion criteria

  • Pregnancy defined as a positive urine HCG
  • Allergy or sensitivity to study drug
  • Stated history of renal insufficiency
  • Documented history of myasthenia gravis
  • Consumption of study drug within 48 hours prior to enrollment
  • Previously enrolled in this trial during a different patient encounter

Treatment and study plan

Magnesium

Drug

Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by magnesium 2 g administered as an intravenous bolus over a period of 20 minutes

Placebo

Drug

Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by placebo (normal saline)

Primary outcomes

  1. Mean change in pain - baseline to 30 minutes

    Time frame: Baseline to 30 minutes after initiation of infusion

    Change in pain score 30 minutes after initiation of infusion. Pain score is measured on a 0-11 point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.

Secondary outcomes

  1. Mean change in pain - baseline to 45 minutes and baseline to 60 minutes

    Time frame: Baseline to 45 minutes and 60 minutes after initiation of infusion

    Change in pain score 45 minutes and 60 minutes after initiation of infusion. Pain score is measured on a 0-11 point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.

  2. Number of adverse events

    Time frame: Infusion through hour 2

    Number of adverse events related to study drug within first 2 hours of study drug infusion. Adverse events include hypotension, flushing, akathisia, dystonia, nausea/vomiting, dizziness, drowsiness.

  3. Emergency Department length of stay

    Time frame: Hour 24

    Total time spent in emergency department up until discharge

  4. Number of patients that require rescue medications

    Time frame: Infusion through hour 2

    Number of patients that require administration of rescue meds, which include acetaminophen, NSAIDs, or additional antidopaminergic agents, given within first 2 hours after infusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc McDowell, PharmD

CONTACT

[email protected]

708-684-1078

Ryan McKillip, MD

CONTACT

[email protected]

708-684-6230

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Evaluating the Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines in the Emergency Department

Acronym: MAGraine2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.