Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines

NCT05967442 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AHC-7192-D5000322
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation describes a proposed clinical trial that will evaluate the relative efficacy of intravenous magnesium sulfate for the treatment of migraine compared to intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the treatment of acute headache and migraine in adult patients. The ultimate objective will be clinical application of these drugs in the emergency department for the treatment of acute headache and migraine. The two phenothiazines (metoclopramide and prochlorperazine) have been routinely utilized in the treatment of acute headache and migraine in the emergency department setting. Per the 2017 American Headache Society guidelines, both intravenous metoclopramide and intravenous procholorperazine are recommended as "clinicians should offer" agents with level B evidence. Of note, there are no agents with level A evidence purported by this guideline for acute management of migraine. The same guideline offers "no recommendation can be made regarding the role of intravenous magnesium for adults who present to the ED with acute migraine. However intravenous magnesium may be of benefit to patients who present with migraine with aura." Multiple trials have evaluated intravenous magnesium's safety and efficacy in the management of acute migraine. These have demonstrated the tolerability of intravenous magnesium on a with breadth of patients. Most commonly the primary adverse event was flushing which self-resolved. No cases of hypotension were reported. None of these study agents have been withdrawn from the market.

Conditions

Migraine; Headache

Keywords

magnesium; migraine; headache

Outcome Measures

Primary Outcomes (1)

• 30 Minute Pain Score

  Scores range from 0-10. A higher score, denotes more pain

  30 minutes after initiation

Secondary Outcomes (2)

• Length of Stay

  From time of arrival to time of discharge.

• Need for Rescue Analgesia

  From time of arrival to time of discharge.

Study Arms (3)

Magnesium

EXPERIMENTAL

Magnesium Sulfate 2gm in 50ml D5W over 20 minutes

Drug: Magnesium Sulfate

Metoclopramide

ACTIVE COMPARATOR

Metoclopramide 10mg in 50ml D5W over 20 minutes

Drug: Metoclopramide 10mg

Prochlorperazine

ACTIVE COMPARATOR

Prochlorperazine in 50ml D5W over 20 minutes

Drug: Prochlorperazine (Compazine) Injection

Interventions

Magnesium Sulfate DRUG

Magnesium Sulfate 2gm in 50ml D5W over 20 minutes

Magnesium

Metoclopramide 10mg DRUG

Metoclopramide 10mg in 50ml D5W over 20 minutes

Metoclopramide

Prochlorperazine (Compazine) Injection DRUG

Prochlorperazine 10mg in 50ml D5W over 20 minutes

Prochlorperazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Magnesium Sulfate; Metoclopramide; Prochlorperazine; Injections

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Phenothiazines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Marc McDowell
• Organization: Advocate Christ Medical Center

marc.mcdowell@aah.org

708684800

Study Officials

• Michael Cirone, MD

  advocate christ medical center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: August 1, 2023
• Study Start: August 23, 2019
• Primary Completion: March 31, 2020
• Study Completion: April 6, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)