Dexketoprofen Trometamol in the Acute Treatment of Migraine Attack: A Phase II, Randomized, Double-Blind, Crossover, Placebo-Controlled, Dose Optimization Study

Migraine is a disabling disease that can significantly affect a person's quality of life. This study assessed the efficacy and tolerability of the 2 doses of dexketoprofen trometamol (DKP) compared to placebo for migraine treatment. Ninety-three patients with at least 1 migraine attack per month in the preceding 6 months were enrolled and randomized to 25 mg DKP, 50 mg DKP, and placebo in a randomized, double-blind, single-center, crossover, placebo-controlled study. Primary endpoint was pain-free episodes 2 hours after drug intake. The presence of accompanying symptoms and adverse effects was also recorded. Seventy-six patients (mean age 40.5 +/- 10.9 and 61% female) completed the study. At baseline, mean number of attacks/month was 3.7 +/- 1.3, with a mean duration of 15.4 +/- 13.5 hours. Prevalence of pain-free episodes after drug intake was significantly reduced by 50 mg DKP vs placebo (33.8 vs 14.7%, P = .0065) whereas the dose of DKP 25 mg was better than placebo but did not reach statistical significance (23 vs 14.7%, P = .1182). Both 25 mg DKP (56.8 vs 25.3%, P = .0002) and 50 mg DKP improved headache relief compared to placebo. Furthermore, both doses of DKP increased the absence of functional disability (25 mg DKP, 39.7 vs 24%, P = .045; and 50 mg DKP, 45.9 vs 24%, P < .0004). Both doses of DKP were effective and well tolerated for acute migraine treatment. Perspective: This article demonstrates the efficacy and tolerability of DKP in the treatment of migraine without and with aura attacks. Its rapid absorption rate with higher maximum plasma concentrations and shorter time to maximum values suggest that this drug is a good option for acute migraine treatment. (C) 2014 by the American Pain Society