Octreotide is not Effective in the Acute Treatment of Migraine

Abstract

The aim of this study was to determine whether subcutaneous octreotide is effective for the treatment of acute migraine. Patients with migraine with and without aura as classified by the International Headache Society were recruited to a double-blind placebo-controlled crossover study. Patients were instructed to treat two attacks of at least moderate pain severity, with at least a 7 day interval, using subcutaneous 100 μg octreotide or matching placebo. The primary endpoint was the headache response defined as: severe or moderate pain becomes mild or nil, at 2 h. The primary endpoint was analysed using a Multilevel Analysis approach. Secondary end-points included associated symptoms and a four-point functional disability score. The study was powered to detect a 30% difference at an α of 0.05 and a β of 0.8. A total of 51 patients were recruited, of whom 42 provided efficacy data on an attack treated with octreotide and 41 with placebo. Modelling the headache response as a binomial determined by treatment, using the patient as the level 2 variable, and considering a possible period effect, and sex and migraine type as other variables of interest, subcutaneous octreotide was not significantly superior to placebo. The two hour headache response rates were 20% for placebo and 14% for octreotide, whilst the two hour pain free rates were 7% and 2%, respectively. Subcutaneous octreotide 100 μg is not effective in the acute treatment of migraine when compared to placebo.