A Randomized, Placebo-Controlled, Double-Blind Study of the Effects of Magnesium Compared to Conventional Therapy on Acute Migraine

ClinicalTrials.gov processed this data on September 10, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified September 2024 by Advocate Health Care

Sponsor

Advocate Health Care

Information Provided by (Responsible Party)

Advocate Health Care

Clinicaltrials.gov Identifier

NCT05967442
Other Study ID Numbers: AHC-7192-D5000322
First Submitted: January 9, 2020
First Posted: August 1, 2023
Results First Posted: October 1, 2024
Last Update Posted: October 1, 2024
Last Verified: September 2024
History of Changes

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Study Description

Migraine or severe headache affected one-fifth of women and one-tenth of men in 2015 and is one of the leading causes of disability in the world. Over one million visits to emergency departments (ED) in the US are due to migraines. Migraine, previously believed to be a vascular disorder, is caused by inflammation due to vasodilation in the meninges secondary to the release of vasoactive neuropeptides by stimulation of the trigeminal nerve. This inflammation can result in symptoms such as headache, nausea, vomiting, dizziness, photophobia and phonophobia.

Despite migraine being a common disorder, there has yet to be a cure. Several classes of medications have been studied for the treatment of migraine. Recently, conventional therapy has shifted to the use of antidopaminergics including prochlorperazine, metoclopramide and haloperidol, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen, and triptans, sumatriptan being the most commonly utilized. 5Although intravenous opioids have historically been the most common treatment for migraines, their use has fallen out of favor due to their association with increased recurrence of headaches and ED visits, abuse potential, and most recently severe intravenous opiate shortage. Alternative treatments include ketamine, propofol, dihydroergotamine and magnesium.

Magnesium is an intracellular cation that has been associated with both the function of serotonin and regulation of vascular tone, which are both mechanisms that implicate its role in the treatment of migraine. Intravenous magnesium sulfate has been studied as a treatment for migraine compared to placebo, metoclopramide and prochlorperazine. These studies have shown that magnesium is well-tolerated with a good safety profile and may be efficacious in the treatment of migraine. Metoclopramide, prochlorperazine and magnesium have been recommended in clinical practice guidelines and have become routine standard of care for treatment of migraine in this emergency department. However, no trial has evaluated these modalities simultaneously in the same population. The purpose of our study is to compare the relative efficacy for magnesium, metoclopramide, and prochlorperazine in the treatment of headache and migraine.

Via monthly block randomization, patients will be given one of three guideline recommended study drugs. Allocation will be concealed by a pharmacist (not participating in the rest of the study) solely designated to choose which drug will be the assigned study drug for each month. The pharmacists, physicians, and nurses participating in administration of the medications will be blinded to which drug is being administered during each month. Metoclopramide, prochlorperazine and magnesium have been recommended in clinical practice guidelines and have become routine standard of care for treatment of migraine in this emergency department. All three study drugs will be stored in the investigational medication refrigerator located in the main pharmacy. A pharmacist on duty in the emergency department will obtain the medication from the refrigerator and deliver it to the bedside nurse who is actively caring for the patient after an order from the physician.

The primary outcome of this study will be mean change in pain from baseline to 30 minutes after initiation of infusion (as defined on a 11-point Numeric Rating Scale. Secondary endpoints include mean change in pain from baseline to 60 minutes and 120 minutes after initiation of infusion (as defined on a 11-point Numeric Rating Scale), time to emergency department discharge, and adverse effects due to administration of study drug (hypotension, flushing, akathisia, dystonia, nausea, vomiting, dizziness, drowsiness, other self-reported adverse effects).
Condition or Disease Intervention/Treatment
  • Migraine
  • Headache
  • Drug: Magnesium Sulfate
  • Drug: Metoclopramide 10mg
  • Drug: Prochlorperazine (Compazine) Injection

Study Design

Study TypeInterventional
Actual Enrollment157 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Placebo-Controlled, Double-Blind Study of the Effects of Magnesium Compared to Conventional Therapy on Acute Migraine
Study Start DateAugust 23, 2019
Actual Primary Completion DateMarch 31, 2020
Actual Study Completion DateApril 6, 2023

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Magnesium
    • Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
  • Drug: Magnesium Sulfate
    • Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
  • Metoclopramide
    • Metoclopramide 10mg in 50ml D5W over 20 minutes
  • Drug: Metoclopramide 10mg
    • Prochlorperazine
      • Prochlorperazine in 50ml D5W over 20 minutes
    • Drug: Prochlorperazine (Compazine) Injection

      Outcome Measures

      Primary Outcome Measures

      1. 30 Minute Pain Score [30 minutes after initiation]
        Scores range from 0-10. A higher score, denotes more pain

      Secondary Outcome Measures

      1. Length of Stay [From time of arrival to time of discharge.]
        Emergency Department Length of stay. Measured from time of arrival to time of discharged documented in the electronic medical record.
      2. Need for Rescue Analgesia [From time of arrival to time of discharge.]
        Percentage of participants who had necessity for rescue analgesics after study drug administration

      Eligibility Criteria

      Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers Yes
      Inclusion Criteria
      • Age > 18 years or older
      • Able to provide informed consent
      • Primary diagnosis of headache or migraine
      • Between October 1, 2018 to April 1, 2020
      • Presenting to Advocate Christ Medical Center emergency department and meet clinical assessment per physician
      Exclusion Criteria
      • Pregnancy defined as a positive urine HCG
      • Stated history of renal impairment
      • Allergy or sensitivity to any study drugs
      • Concomitant treatment at the time of study drug administered in the emergency department
      • Patients with a history of this study participation

      Contacts and Locations

      Sponsors and Collaborators Advocate Health Care
      Locations
      • Advocate Christ Medical Center | Oak Lawn, Illinois, United States, 60453

      Study Documents (Full Text)

      More Information

      Additional Relevant MeSH Terms

      • Migraine Disorders
      • Headache
      • Headache Disorders, Primary
      • Headache Disorders
      • Brain Diseases
      • Central Nervous System Diseases
      • Nervous System Diseases
      • Pain
      • Neurologic Manifestations