Efficacy and Safety of MIGSPRAY for Migraine Prevention in Children and Pregnant Women: A Randomized Double-Blind Trial
Abstract
Background: Migraine is a prevalent neurological condition that significantly impacts the quality of life, particularly in vulnerable populations such as children and pregnant women. Pharmacological 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, double-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 repeated-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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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