Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines (MAGraine)
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ClinicalTrials.gov Identifier: NCT05967442 |
Recruitment Status :
Completed
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
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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None of these study agents have been withdrawn from the market.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Headache | Drug: Magnesium Sulfate Drug: Metoclopramide 10mg Drug: Prochlorperazine (Compazine) Injection | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 288 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind Study of the Effects of Magnesium Compared to Conventional Therapy on Acute Migraine |
Actual Study Start Date : | August 23, 2019 |
Actual Primary Completion Date : | March 31, 2020 |
Actual Study Completion Date : | April 6, 2023 |
Arm | Intervention/treatment |
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Experimental: Magnesium |
Drug: Magnesium Sulfate
Magnesium Sulfate 2gm in 50ml D5W over 20 minutes |
Active Comparator: Metoclopramide
Metoclopramide 10mg in 50ml D5W over 20 minutes
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Drug: Metoclopramide 10mg
Metoclopramide 10mg in 50ml D5W over 20 minutes |
Active Comparator: Prochlorperazine
Prochlorperazine in 50ml D5W over 20 minutes
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Drug: Prochlorperazine (Compazine) Injection
Prochlorperazine 10mg in 50ml D5W over 20 minutes |
- 30min pain score [ Time Frame: 30 minutes after initiation ]11 point Numerical Rating Scale pain score at 30 minutes after initiation of drug
- LOS [ Time Frame: Upon discharge ]Emergency Department Length of stay. Measured from time of arrival to time of discharged documented in the electronic medical record. Duration measured in minutes
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05967442
United States, Illinois | |
Advocate Christ Medical Center | |
Oak Lawn, Illinois, United States, 60453 |
Responsible Party: | Marc Mcdowell, Principle investigator, Advocate Health Care |
ClinicalTrials.gov Identifier: | NCT05967442 |
Other Study ID Numbers: |
AHC-7192-D5000322 |
First Posted: | August 1, 2023 Key Record Dates |
Last Update Posted: | August 1, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
magnesium migraine headache |
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Magnesium Sulfate Metoclopramide Prochlorperazine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents Antiemetics Autonomic Agents Gastrointestinal Agents Dopamine D2 Receptor Antagonists |