The purpose of this study is to evaluate the impact of the Migraceutics® phase-specific dietary supplement regimen on quality of life, work productivity, and biomarkers in adult migraineurs.
Self-reported history of migraine, based on the International Headache Society (IHS) International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for migraine.
Being able to take oral supplements.
Agreeing to maintain their regular lifestyle.
Access to internet and telephone.
Pregnancy or lactation.
Presence of any active medical condition or diagnosis other than episodic migraine, including liver or kidney disease or condition.
Use of overlapping supplements or interacting medications.
Known allergies to study ingredients.
Parallel
Foundational dietary supplement
Dietary supplementFoundational dietary supplement, self-administered daily.
Luteal phase dietary supplement add-on
Dietary supplementAdd-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.
Migraine phase dietary supplement add-on
Dietary supplementAdd-on dietary supplement, self-administered during the symptomatic migraine phase.
Reference dietary supplement
Dietary supplementReference comparator supplement, self-administered daily.
Changes from baseline in migraine-related quality of life
Changes from baseline in migraine-related quality of life as measured by the mean Headache Impact Test (HIT-6) total score. HIT-6 has six questions, which are rated using a five-level scale: Never (6 points), Rarely (8 points), Sometimes (10 points), Very Often (11 points), and Always (13 points). Total scores can range from 36 to 78, with higher totals reflecting a more significant impact.
Number of self-reported migraine days per month
The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine.
Distribution of participants experiencing changes in monthly migraine days
Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline.
Use of over-the-counter or prescription migraine or headache medication
Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication
Migraine symptoms participants experienced
Mean monthly number of migraine symptoms.
Change from baseline in systemic CGRP concentrations
Mean systemic CGRP concentrations.
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