Efficacy and Safety of MIGSPRAY for Migraine Prevention in Children and Pregnant Women: A Randomized Double-Blind Trial

Background: Migraine is a prevalent neurological condition that significantly impacts the quality of life, particularly in vulnerable populations such as children and pregnant women. Pharmacologi[1]cal options are limited in these groups due to safety concerns, highlighting the need for alternative treatments. MIGSPRAY, a novel nasal spray with mechanical barrier and osmotic properties, offers a non-pharmacological option for migraine prevention. Objective: To evaluate the efficacy and safety of MIGSPRAY in reducing the frequency, intensity, and disability associated with migraines in children and pregnant women through a randomized, dou[1]ble-blind, placebo-controlled clinical trial. Methods: This 90 days study enrolled 42 participants, including 16 children (aged 3 years-18 years) and 16 pregnant women, randomized in a 1:1 ratio to receive either MIGSPRAY or a placebo. The primary endpoint was the reduction in the frequency of migraine days. Secondary endpoints included changes in disability (MIDAS, HIT-6 scores), and adverse events. Statistical analyses were conducted using re[1]peated-measures ANOVA, and safety was assessed through adverse event reporting. Results: MIGSPRAY significantly reduced the frequency of migraine days compared to placebo, with reductions becoming more pronounced by day 60 (p=0.016 for children; p=0.014 for pregnant women) and day 90 (p=0.003 for children; p=0.008 for pregnant women). Conclusion: MIGSPRAY demonstrated significant efficacy in reducing migraine frequency, intensity, and associated disability in children and pregnant women, with a favorable safety profile. These findings suggest that MIGSPRAY is a viable non-pharmacological option for migraine prevention in populations where traditional treatments are limited.