No abstract

Lanepitant, a potent non-peptide neurokinin-1 receptor antagonist, inhibits neurogenic dural inflammation, and may have a role in migraine therapy. This study evaluated the effect of lanepitant taken daily for migraine prevention. Patients with migraine headaches with and without aura by International Headache Society classification criteria were enrolled in a 12-week double-blind, parallel design study comparing the effect of 200 mg qd lanepitant (n = 42) and placebo (n = 42) on reduction of migraine frequency. The primary outcome measure was response rate, i.e. the proportion of patients with a 50% reduction in days of headache. Of the 84 patients enrolled, 90.5% were female. The endpoint response rate for lanepitant-treated patients (41.0%) was not statistically significantly (P = 0.065) greater than that for placebo-treated patients (22.0%). No efficacy variables differed significantly between treatments, except for response rates at month 3 (P = 0.045). Higher plasma concentrations were no more effective than lower concentrations. In this study lanepitant was not effective in preventing migraine, but was well tolerated. These results do not support a role for NK-1 antagonism in migraine prevention.

Subcommittee has done a great service in establishing standard efficacy parameters for migraine trials. We agree with the proposal that Pain-free at 2 h be used as the primary efficacy variable because of its clinical relevance and lack of ambiguity.We have given this matter a great deal of thought in developing our clinical protocols for the treatment of acute migraine. We would like to suggest some additional terminology and definitions that will (i) minimize confusion in the literature and (ii) help link new terminology with prior terminology that has been used in the literature. We hope that the additional terminology will be a valuable addition to the committee's work.The efficacy variables would be collected at and analyzed for various times after dosing. Based on the existing literature, the standard time is at 2 h (1) which has been used for sumatriptan (2, 3), zolmitriptan (4), and rizatriptan (5). Additional times after dosing may also be chosen. For example, 4 h has been used for naratriptan (6). International Headache Society Committee on Clinical Trials inMigraine. Guidelines for controlled trials of drugs in migraine. First edition. Cephalalgia 1991;11:1-12 Cutler N, Mushet GR, Clements B, Whitcher L. Oral sumatriptan for the acute treatment of migraine: evaluation of three dosage strengths. Neurology 1995;45 Suppl 7:S5-S9 Sargent J, Kirchner JR, Davis R, Kirkhart B. Oral sumatriptan is effective and well tolerated for the acute migraine: results of a multicenter study. Neurology 1995;45 Suppl 7:SlO-14 Rapoport AM, Ramadan NM, Adelman JU, Mathew NT, Elkind AH, Kudrow DB, et al. on behalf of the 017 Clinical Trial Study Group. Optimizing the dose of zolmitriptan (Zomig, *311C90) for the acute treatment of migraine. A multicenter, double-blind, placebo-controlled, dose rangefinding study. Neurology 1997;49:1210 -8 Gijsman H, Kramer MS, Sargent J, Tuchman M, Matzura-Wolfe D. Double-blind, placebo-controlled, dose-finding study of rizatriptan (MK-462) in the acute treatment of migraine. Cephalalgia 1997;17647 -51 Klassen A, Elkind A, Asgharnejad M, Webster C, Laurenza A, on behalf of the Naratriptan S2WA3001 Study Group. Naratriptan is effective and well tolerated in the acute treatment of migraine. Results of a double-blind, placebocontrolled, parallel-group study. Headache 1997;37640 -5 Mathew NT, Asghamejad M, Peykamian M, Laurenza A, on behalf of the Naratriptan S2WA3003 Study Group. Naratriptan is effective and well tolerated in the acute treatment of migraine. Results of a double-blind, placebo-controlled, crossover study. Neurology 1997;49:1485 -90 DJ Goldstein, WW O@n, MB Moster, Neuroscience Therapeutic