Brief Communication Frovatriptan for Prophylactic Treatment of Cluster Headache: Lessons for Future Trial Design Lutz Pageler, MD; Zaza Katsarava, MD, PhD; Christian Lampl, MD, PhD; Andreas Straube, MD, PhD; Stefan Evers, MD, PhD; Hans-Christoph Diener, MD, PhD; Volker Limmroth, MD, PhD Objective.—The aim of this study was to determine whether frovatriptan would show efficacy in short term prophylactic treatment of episodic cluster headache (ECH) in comparison to placebo. From the Department of Neurology, Cologne City Hospitals, Cologne, Germany (L. Pageler and V. Limmroth); Department of Neurology, University of Duisburg-Essen, Essen, Gemary (Z. Katsarava and H.-C. Diener); Department of Neurology, Konventhos- pital der Barmherzigen Brüder Linz, Seilerstätte, Linz, Austria (C. Lampl); Department of Neurology, University of Munich, Marchioninistraße, München, Gemary (A. Straube); Department of Neurology, University of Münster, Münster, Germany (S. Evers). The study was sponsored by Berlin-Chemie/Menarini. The statistical analysis was performed by FGK Clinical Research GmbH. The authors had unlimited access to all data. The study is registered under the EudraCT Number 2004-004999-361 at the EMA. Address all correspondence to L. Pageler, Department of Neurology, Cologne City Hospitals, Ostmerheimer Street 200, 51109 Cologne, Germany. Accepted for publication July 15, 2010. Conflict of Interest: Dr. Lutz Pageler received honoraria for oral presentations from: Berlin-Chemie, GlaxoSmithKline, and Janssen-Cilag. Headache research at the Department of Neurology in Essen was supported by the German Ministry of Education and Research (BMBF). Dr. Zaza Katsarava received consulting fees from Allergan, and research grants from Bayer and Allergan. Dr. Christian Lampl received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from:AstraZeneca, Bayer, Biogen, GlaxoSmithKline, Grünenthal, Janssen-Cilag, Mundipharma, MSD, Pfizer. Financial support for research projects was provided by AstraZeneca, Bayer, Pfizer, Grünenthal. Christian Lampl has no ownership interest and does not own stocks of any pharmaceutical company. Prof. Dr. Andreas Straube received honoraria for oral presentations from Almirall, MSD,Allergan, Böhringer Ingelheim, and Berlin-Chemie. Prof. Dr. Stefan Evers received honoraries and research grants from the following pharmaceutical companies: Astra Zeneca, GSK, Berlin Chemie, Allergan, MSD, Boehringer Ingelheim, Ipsen, Addex, Pfizer. He declares no conflicts of interest in this paper. Prof. Dr. Hans-Christoph Diener received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Addex Pharma, Allergan, Almirall, AstraZeneca, Bayer Vital, Berlin-Chemie, CoLucid, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Grünenthal, Janssen-Cilag, Lilly, La Roche, 3MMedica, MSD, Novartis, Johnson&Johnson, Pierre Fabre, Pfizer, Schaper and Brümmer, Sanofi-Aventis,Weber&Weber. Financial support for research projects was provided by Allergan, Almirall, AstraZeneca, Bayer, GSK, Janssen-Cilag, Pfizer. Headache research at the Department of Neurology in Essen is supported by the German Research Council (DFG), the German Ministry of Education and Research (BMBF), and the European Union. H.C. Diener has no ownership interest and does not own stocks of any pharmaceutical company. Prof. Dr.Volker Limmroth received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Addex Pharma, Allergan, Almirall, AstraZeneca, Bayer Vital, Berlin-Chemie, Boehringer Ingelheim, GlaxoSmithKline, Janssen-Cilag, MSD, Novartis, Johnson&Johnson, Pfizer, Sanofi-Aventis. Headache research at the Department of Neurology in Essen is supported by the German Research Council (DFG), the German Ministry of Education and Research (BMBF), and the European Union. ISSN 0017-8748 doi: 10.1111/j.1526-4610.2010.01772.x Published by Wiley Periodicals, Inc. Headache © 2010 American Headache Society 1