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Recruiting NCT06904287

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

Phase III Interventional Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnesium, Placebo.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Mean change in pain - baseline to 30 minutes [Time frame: Baseline to 30 minutes after initiation of infusion]
Secondary outcome measures (4)
  • 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]
  • Number of adverse events [Time frame: Infusion through hour 2]
  • Emergency Department length of stay [Time frame: Hour 24]
  • Number of patients that require rescue medications [Time frame: Infusion through hour 2]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Advocate Christ Medical Center Emergency Department — Oak Lawn

Identifiers

NCT: NCT06904287 · IRB00127959

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗