Randomized, placebo-controlled trial of rofecoxib in the acute treatment of migraine.

Objective: To investigate the clinical profile of rofecoxib, a long-acting (≈17-hour half-life) selective cyclo-oxygenase-2 inhibitor, for the acute treatment of migraine. Methods: A randomized, double-blind, placebo-controlled, parallel-group study was conducted. Patients age ≥18 treated a moderate or severe migraine headache with placebo (n = 182), rofecoxib 25 mg (n = 183), or rofecoxib 50 mg (n = 192). The primary efficacy measure was headache relief (mild or no pain) 2 hours after dose. Results: The proportions of patients with migraine headache relief at 2 hours after dose were 34.3% for placebo, 54.0% for rofecoxib 25 mg ( p p Conclusion: Rofecoxib 25 and 50 mg were effective and generally well tolerated for the acute treatment of migraine attacks.