Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines (MAGraine2)

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

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

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Magnesium; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ryan McKillip, MD; Phone Number: 708-684-6230; Email: ryan.mckillip@aah.org
• Study Contact Backup: Name: Marc McDowell, PharmD; Phone Number: 708-684-1078; Email: marc.mcdowell@aah.org

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Advocate Christ Medical Center Emergency Department
      • Contact: Samar Ashrafi, PharmD; Phone Number: 708-684-7895; Email: samar.ashrafi@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Drug; Prochlorperazine 10 mg followed by Magnesium 2 g	Drug: Magnesium; 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
Active Comparator: Control Arm; Prochlorperazine 10 mg followed by placebo	Drug: Placebo; Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by placebo (normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in pain - baseline to 30 minutes	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.	Baseline to 30 minutes after initiation of infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in pain - baseline to 45 minutes and baseline to 60 minutes	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.	Baseline to 45 minutes and 60 minutes after initiation of infusion
Number of adverse events	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.	Infusion through hour 2
Emergency Department length of stay	Total time spent in emergency department up until discharge	Hour 24
Number of patients that require rescue medications	Number of patients that require administration of rescue meds, which include acetaminophen, NSAIDs, or additional antidopaminergic agents, given within first 2 hours after infusion.	Infusion through hour 2

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ryan McKillip, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; Magnesium
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Inorganic Chemicals; Elements; Metals, Light; Metals; Metals, Alkaline Earth; Magnesium
• Other Study ID Numbers: IRB00127959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No