Magnesium + Prochlorperazine for Migraine

(MAGraine2 Trial)

RM
MM
Overseen ByMarc McDowell, PharmD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding magnesium, a mineral supplement, to the usual migraine treatment, prochlorperazine, can more effectively reduce migraine pain. Participants will receive either prochlorperazine with magnesium or prochlorperazine with a placebo, which mimics the real treatment. Individuals diagnosed with migraines that are often one-sided, pounding, or accompanied by nausea may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking advancements in migraine treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that magnesium is generally safe and well-tolerated for treating migraines. Studies have found that magnesium, when used with prochlorperazine, has a good safety record. Although prochlorperazine may cause fewer side effects than magnesium, both are considered safe. Prochlorperazine effectively relieves headaches but can have more side effects than magnesium. Overall, magnesium is seen as safe, especially when taken orally. Therefore, participants in the trial can expect the treatment to be safe based on earlier studies.12345

Why do researchers think this study treatment might be promising for migraine?

Researchers are excited about using magnesium in combination with prochlorperazine for migraines because magnesium offers a unique approach compared to standard treatments like triptans and NSAIDs. Magnesium is thought to help by stabilizing nerve cells and reducing inflammation, which could provide relief for migraine sufferers. Additionally, the combination with prochlorperazine, which is already used to treat migraines, could enhance its effectiveness and provide a new, synergistic treatment option. This dual-action approach has the potential to offer faster relief and target migraines from multiple angles, which is a promising development for those who need quick and effective management of their symptoms.

What evidence suggests that this trial's treatments could be effective for migraine?

This trial will compare the combination of magnesium and prochlorperazine with prochlorperazine alone. Research has shown that using magnesium with prochlorperazine can help reduce migraine pain. Studies have found that prochlorperazine effectively relieves sudden headaches in 80% to 88% of cases. Magnesium has also been shown to reduce the number of migraine days by 22% to 43%. The MAGraine study found that combining magnesium and prochlorperazine effectively reduces pain. Both treatments are generally safe, with magnesium having fewer side effects when taken orally.12345

Who Is on the Research Team?

RM

Ryan McKillip, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Study DrugExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

NCT06904287 | Effectiveness of Magnesium in Addition to ...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.
MAGraine: Magnesium compared to conventional therapy for ...The results of the MAGraine study demonstrated that IV magnesium sulfate, metoclopramide, and prochlorperazine were effective in decreasing pain ...
A prospective study of i.v. magnesium and ...Previous randomized, double-blind trials have shown prochlorperazine to be 80–88% effective in the resolution of acute headaches (2). Nonrandomized, nonblinded ...
Magnesium and MigraineThis classification is supported by findings from five clinical trials (1990–2016) that showed a reduction in migraine days by 22–43% and indicated that high ...
Magnesium + Prochlorperazine for Migraine (MAGraine2 ...Prochlorperazine caused fewer side effects compared to magnesium in one study, and magnesium is generally considered safe, especially when taken orally.
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