A double-blind crossover comparison of the effects of vigabatrin with placebo in the prevention of migraine headache

Abstract

Twenty-three patients, aged 18‐66 years and suffering from migraine with or without aura, were randomly selected to receive either vigabatrin or matched placebo tablets first for 12 weeks in a double-blind crossover study. Alternative treatment was given after a 4-week washout period. The dose of medication was titrated to a maximum of 4 tablets (2 g vigabatrin) daily according to patients' tolerance during the first six weeks of each treatment. No further dosage adjustment was made. Apart from rescue medication for migraine, no other drug was permitted. Four patients dropped out and four were excluded for non-compliance. Compared to placebo, vigabatrin decreased the frequency (p=0.017) and severity (p=0.024) of headache modestly. However, it reduced the duration (p=0.019) of headache and migraine index (p=0.012) considerably by 40% and 59%, respectively. No serious adverse effects were observed. Serum vigabatrin levels showed no correlation with the clinical effects.