Gelstat Migraine (sublingually administered feverfew and ginger compound) for acute treatment of migraine when administered during the mild pain phase.

BACKGROUND Treatment of migraine headaches is often delayed due to assessing the potential severity of an evolving headache or anticipating unwanted consequences from prescription medication. Studies have demonstrated improved pain-free response when prescription treatments are taken during the mild headache phase of a migraine. This study was designed to evaluate the efficacy of an OTC product, GelStat Migraine, when taken in the early, mild pain phase of migraine. MATERIAL/METHODS An open-label study enrolling 30 subjects, male and female, with a one-year history of migraine meeting IHS diagnostic criteria with or without aura, 2-8 migraines per month and < or = 15 headache days per month. Inclusion required having migraines that consistently started at mild and worsened to moderate or severe, if untreated, in at least 75% of attacks. Subjects also had to be able to distinguish migraine from non-migraine headaches and reliably identify migraine early in the course of an attack. One headache was treated in the mild pain phase with GelStat Migraine, a combination of feverfew and ginger. RESULTS 29 evaluable subjects completed the study, all treating at mild pain. Two hours after treatment, 48% were pain-free with 34% reporting a headache of only mild severity. 29% reported a recurrence within 24 hours. Side effects were minimal and not serious. 59% of subjects were satisfied with Gelstat Migraine therapy and 41% preferred GelStat Migraine or felt it was equal to their pre-study medication. CONCLUSIONS GelStat Migraine is effective as a first line abortive treatment for migraine when initiated early during the mild headache phase.