A double-blind placebo-controlled trial of nabumetone in the prophylaxis of migraine

Objective: To assess the safety of nabumetone in the prophylaxis of migraine. Study Design: Placebo-controlled, double-blind, parallel trial of nabumetone 1000mg daily. Patient Selection: Patient with history of migraine with or without aura according to IHS criteria. Patients with a history of 2 to 8 migraine attacks per month. Tension-type headaches permissible if the number of tension-type headaches per month were less than the number of migraine headaches. Main Outcome Measures: Headache frequency, adverse events, patient, and physician global assessments. Results: Eleven males and 68 females were enrolled in the trial. Eight patients failed to randomize. The global assessment by physician and patient alike revealed that 13 patients on nabumetone had a positive response and eight failed to improve. By comparison, 15 patients on placebo felt improved and 14 failed to note any improvement. The mean headache frequency decreased from a mean of four headaches per month in both active and placebo groups to 2.722 in the active group and to an increase of 4.0385 in the placebo group. These were not statistically significant. Adverse events were widely distributed in types and between active and placebo groups without apparent significant difference. Conclusions: Nabumetone is a well-tolerated medication which may have limited beneficial effects in the prophylaxis of migraine.