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A double‐blind, randomized, placebo‐controlled, single‐dose study of the cyclooxygenase‐2 inhibitor, GW406381, as a treatment for acute migraine
Author(s) -
Wentz A. L.,
Jimenez T. B.,
Dixon R. M.,
Aurora S. K.,
Gold M.
Publication year - 2008
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/j.1468-1331.2008.02093.x
Subject(s) - medicine , migraine , placebo , double blind , cyclooxygenase , acute migraine , anesthesia , triptans , pharmacology , alternative medicine , pathology , biochemistry , chemistry , enzyme
The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase‐2 (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 (protocol number CXA20008). Three hundred and thirty‐seven subjects were randomized 1:1:1 to GW406381 (70 mg), naproxen sodium (825 mg), or placebo for 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 3 (severe) to 0 (no pain) or 1 (mild)] at 2 h post‐dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated with GW406381 (50%, P = 0.032) or naproxen sodium (56%, P = 0.005) than with placebo (35%) reported headache relief at 2 h post‐dose. Additional significant benefits were observed on many secondary outcomes, including proportions of subjects pain‐free, for both GW406381 and naproxen sodium treatment compared with placebo. Both active treatments were well tolerated. Single‐dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tolerated in the treatment of acute migraine.