Research Submission Rizatriptan 10-mg ODT for Early Treatment of Migraine and Impact of Migraine Education on Treatment Response Roger K. Cady, MD; Vincent T. Martin, MD; Gilles Géraud, MD; Anthony Rodgers, MS; Ying Zhang, PhD; Andrew P. Ho, MD; Carolyn M. Hustad, PhD; Tony W. Ho, MD; Kathryn M. Connor, MD; Karen E. Ramsey, RPh Objective.—To examine the efficacy of rizatriptan 10-mg orally disintegrating tablet (ODT) for treating migraines of mild intensity soon after onset, with or without patient-specific migraine education. Background.—Studies have shown rizatriptan tablet efficacy in early migraine treatment. Methods.—In this randomized, placebo-controlled, double-blind, factorial design study, adults with a history of migraine were assigned to rizatriptan 10-mg ODT  patient education (personalized summary of early migraine signs and symptoms) or placebo  patient education in a 1 : 1 : 1 : 1 ratio. Patients were instructed to treat 1 attack at the earliest time they knew that their headache was a migraine, while pain was mild. During the next 24 hours, patients assessed pain severity, associated symptoms, functional disability, use of rescue medication, and treatment satisfaction. The primary endpoint was pain freedom at 2 hours; a key secondary endpoint was 24-hour sustained pain freedom. Results.—Of 207 patients randomized to treatment, 188 (91%) treated a study migraine. Significantly more patients taking rizatriptan reported pain freedom at 2 hours compared with placebo (66.3% vs 28.1%, P < .001). Similarly, significantly more patients taking rizatriptan reported 24-hour sustained pain freedom (52.2% vs 17.7%, P < .001). A greater proportion of patients in the rizatriptan + education group reported pain freedom at 2 hours compared with those in the rizatriptan + no education group (71.7% vs 60.9%, P = .430). Few adverse events were reported. Conclusion.—Rizatriptan 10-mg ODT, when taken early, while headache pain is mild, was superior to placebo at providing pain freedom at 2 hours and 24-hour sustained pain freedom (NCT00516737). Key words: rizatriptan, migraine, efficacy, early treatment, education Abbreviations: AE adverse experience, CI confidence interval, HCP healthcare provider, IVRS Interactive Voice Response System, ODT orally disintegrating tablet, TAME Treat A Migraine Early (Headache 2009;49:687-696) Studies of triptan efficacy conducted for regu- latory approvals required that study medications be administered only after the migraine headache pain became moderate or severe in intensity. Clinical observations and post-hoc analyses of protocol viola- tors have suggested that administration of medication From the Banyan Group Inc., Springfield, MO, USA (R.K. Cady); University of Cincinnati, Cincinnati, OH, USA (V.T. Martin); Department of Neurology, Hospital Rangueil, Tou- louse, France (G. Géraud); Merck & Co., Inc., North Wales, PA, USA (A. Rodgers, Y. Zhang, A.P. Ho, C.M. Hustad, T.W. Ho, K.M. Connor, K.E. Ramsey). Address all correspondence to R.K. Cady, Headache Care Center, 3805 S. Kansas Expressway, Springfield, MO 65807, USA. Funding support: This study was funded by Merck & Co., Inc. Accepted for publication December 20, 2008. Conflict of Interest: Drs. Cady and Martin have received research grants and honoraria from Merck & Co., Inc. Dr. Geraud has received research grants and honoraria from Merck & Co., Inc. Mr. Rodgers, Ms. Ramsey, and Drs. Ho, Hustad, Zhang, Connor, and Ho are employed by Merck & Co., Inc. and may own stock or hold stock options in the company. ISSN 0017-8748 doi: 10.1111/j.1526-4610.2009.01412.x Published by Wiley Periodicals, Inc. Headache © 2009 the Authors Journal compilation © 2009 American Headache Society 687