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

NCT06904287 | Recruiting Phase 3 FDA Drug

• 1 other identifier: IRB00127959
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Keywords

Migraine; Magnesium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean change in pain - baseline to 45 minutes and baseline to 60 minutes

  Baseline to 45 minutes and 60 minutes after initiation of infusion

• Number of adverse events

  Infusion through hour 2

• Emergency Department length of stay

  Hour 24

• Number of patients that require rescue medications

  Infusion through hour 2

Study Arms (2)

Study Drug

EXPERIMENTAL

Prochlorperazine 10 mg followed by Magnesium 2 g

Drug: Magnesium

Control Arm

ACTIVE COMPARATOR

Prochlorperazine 10 mg followed by placebo

Drug: Placebo

Interventions

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

Study Drug

Placebo DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years or older
• Able to provide informed consent
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Christ Medical Center Emergency Department

Oak Lawn, Illinois, 60453, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Magnesium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Ryan McKillip, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan McKillip, MD

CONTACT

708-684-6230; ryan.mckillip@aah.org

Marc McDowell, PharmD

CONTACT

708-684-1078; marc.mcdowell@aah.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 1, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)