Levetiracetam in chronic daily headache: A double-blind randomised placebo-controlled study

Cephalalgia, 11/16/2010

Chronic daily headache (CDH) represents a temporal profile of headache (15+ days/month; 4+ hours/day; >6 months). Authors report the first comprehensive and largest levetiracetam (LEV) trial in CDH. A 27–week, multi–centre, randomised, placebo–controlled, cross–over, phase III B study assessed efficacy of a target of 3 g/day LEV of 6 placebo tablets/day in CDH. Primary efficacy was headache–free rate (HFR) while secondary parameters were loss of diagnostic criteria; severity; duration; disability; associated features; pain; and quality of life. The findings conflict with reports of LEV efficacy, mandating placebo control in headache trials. Primary efficacy equated to one extra headache–free day/month with reduced disability and pain intensity. Mental health was reduced on LEV. The 10% loss of diagnostic criteria, decreased intensity and disability suggest a subpopulation with CDH where LEV remains a therapeutic option.

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