Magnesium + Prochlorperazine for Migraine

(MAGraine2 Trial)

Overseen By Marc McDowell, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy, Renal insufficiency, Myasthenia gravis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot have taken the study drug within 48 hours before joining the trial.

What data supports the effectiveness of the drug Magnesium for treating migraines?

Research shows that magnesium can help relieve migraines, especially when given intravenously (directly into the bloodstream). Some studies found that people with migraines often have low magnesium levels, and taking magnesium can quickly ease their symptoms. ^{1 2 3 4 5}

Is the combination of magnesium and prochlorperazine safe for treating migraines?

Magnesium and prochlorperazine have been studied separately for treating migraines, and both have shown good safety profiles. Prochlorperazine caused fewer side effects compared to magnesium in one study, and magnesium is generally considered safe, especially when taken orally. ^{3 6 7 8 9}

How does the drug Magnesium + Prochlorperazine for Migraine differ from other treatments?

The combination of magnesium and prochlorperazine for treating migraines is unique because it combines magnesium, which can help with migraines by affecting various brain chemicals and receptors, with prochlorperazine, a medication often used for nausea and headaches. This combination may offer a different approach by potentially enhancing the effectiveness of migraine relief compared to using each drug alone. ^{3 6 7 10 11}

What is the purpose of this trial?

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

Research Team

Ryan McKillip, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 who can consent, speak English, and have been diagnosed with migraines characterized by recurrent, one-sided, pounding headaches often with nausea. It's not for those allergic to the study drugs, with kidney issues, pregnant women or if they've taken the study drug within two days before joining.

Inclusion Criteria

Able to provide informed consent

English speaking

I have been diagnosed with migraine and my headaches match typical migraine symptoms.

Exclusion Criteria

Allergy or sensitivity to study drug

I have a history of kidney problems.

Consumption of study drug within 48 hours prior to enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive intravenous prochlorperazine followed by magnesium or placebo for migraine treatment

1 day

1 visit (in-person)

Observation

Participants are monitored for changes in pain score and adverse events for up to 2 hours after infusion

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including emergency department length of stay

24 hours

1 visit (in-person)

Treatment Details

Interventions

• Magnesium

Trial Overview Researchers are testing whether adding magnesium to prochlorperazine (a medication already used) provides better relief from migraine pain compared to using prochlorperazine alone. Participants will be randomly given either magnesium or a placebo alongside prochlorperazine.

Participant Groups

Group I: Study Drug Experimental Treatment 1 Intervention

Prochlorperazine 10 mg followed by Magnesium 2 g

Group II: Control Arm Active Control 1 Intervention

Prochlorperazine 10 mg followed by placebo

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Magnesium in the prophylaxis of migraine--a double-blind placebo-controlled study. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Role of magnesium in the pathogenesis and treatment of migraines. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of intravenous magnesium sulfate in the treatment of acute migraine attacks. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The use of intravenous magnesium sulphate for acute migraine: meta-analysis of randomized controlled trials. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

A prospective study of i.v. magnesium and i.v. prochlorperazine in the treatment of headaches. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of rectal prochlorperazine for the treatment of migraine in the emergency department. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of acetaminophen and ibuprofen in children with migraine receiving preventive treatment with magnesium. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headaches: a prospective, randomized, double-blind trial. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

MAGraine: Magnesium compared to conventional therapy for treatment of migraines. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine. [2019]