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

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Magnesium

Study type: Interventional

Funder types: Other

Identifiers

NCT06904287

IRB00127959

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Study Drug

Experimental group

Description:

Prochlorperazine 10 mg followed by Magnesium 2 g

Treatment:

Drug: Magnesium

Control Arm

Active Comparator group

Description:

Prochlorperazine 10 mg followed by placebo

Treatment:

Drug: Placebo