Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study.

Objective The current study evaluated the consistency of eletriptan response. Methods Using a within-patient crossover design, patients with migraine completed a three-attack, open-label, lead-in period, before being treated, double-blind for four attacks, with either eletriptan 40mg (ELE-40; N=539) or eletriptan 80mg (ELE-80; N=432); placebo was randomly substituted for the treatment of one attack. Results On an a priori analysis of within-patient consistency, double-blind treatment was associated with similar 2 hour headache response rates using a 2/3 response criterion for ELE-40 (77%) and ELE-80 (73%), and using a 3/3 response criterion for ELE-40 (46%) and ELE-80 (47%). Within-patient consistency in achieving pain-free status at 2 hours using a 2/3 criterion was slightly higher on ELE-40 (42%) compared with ELE-80 (38%), and was similar using the 3/3 criterion (18% on ELE-40, 17% on ELE-80). On a repeated measures logistic regression analysis across all treated attacks, the probability of achieving a headache response at 2 hours ranged from 71% to 74% on ELE-40 vs. 17% to 28% on placebo (p<0.0001), and from 66% to 74% on ELE-80 vs. 21% to 27% on placebo (p<0.0001). The incidence, per attack, of adverse events was low for both ELE-40 and ELE-80. Few adverse events occurred with incidence 10% on ELE-40 (asthenia, 5.0%) or ELE-80 (asthenia, 10%; nausea, 5.8%). Discontinuations because of adverse events were 0.2% on ELE-40, and 1.6% on ELE-80 Conclusion In this multiple attack study, eletriptan was well-tolerated and demonstrated consistent and significant efficacy in the treatment of migraine. Clinicaltrials.Gov Identifier: NCT01859481