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

Phase 3

Not yet recruiting

• Conditions: Migraine
• Interventions: Drug: Magnesium; Drug: Placebo

• Registration Number: NCT06904287
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Study Start: 2025-08
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Drug	Magnesium	Prochlorperazine 10 mg followed by Magnesium 2 g
Control Arm	Placebo	Prochlorperazine 10 mg followed by placebo

Primary Outcome Measures

Name	Time	Method
Mean change in pain - baseline to 30 minutes	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 Outcome Measures

Name	Time	Method
Mean change in pain - baseline to 45 minutes and baseline to 60 minutes	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.
Number of adverse events	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.
Emergency Department length of stay	Hour 24	Total time spent in emergency department up until discharge
Number of patients that require rescue medications	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.

Trial Locations

Locations (1)

Advocate Christ Medical Center Emergency Department; 🇺🇸 Oak Lawn, Illinois, United States