A Double-blind, randomized, placebo-controlled, single-dose study of the cyclooxygenase-2 inibitor, GW406381, as a treatment for acute migraine.

The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase2(COX-2) inhibitor with relatively high CNS penetration in acute migraine. This was a double.blind, single dose study of GW406381, compared with placebo and naproxen sodium compared with placebo. Three hundred and tirthy-seven subjects were randomized 1:1:1 to GW406381 (70 mg), Naproxen sodium (825 mg) or placebo foe the treatment of one migraine headache of moderate or severe intensity in a potential 8-week period. The primary end-point was the proportion of subjects with headache relief, reduction in headache severity score from pre-dose 2 (moderate) or severe (3) to 0 (no pain) or 1 (mild) at 2 post-dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated whit GW406381 or naproxen sodium that with placebo reported relief at 2 h post-dose. Single dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tollerated in the treatment of acute migraine