Magnesium + Prochlorperazine for Migraine
(MAGraine2 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous prochlorperazine followed by magnesium or placebo for migraine treatment
Observation
Participants are monitored for changes in pain score and adverse events for up to 2 hours after infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment, including emergency department length of stay
What Are the Treatments Tested in This Trial?
Interventions
- Magnesium
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor