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The Journal of Headache and Pain logoLink to The Journal of Headache and Pain
. 2009 Nov 6;11(1):33–44. doi: 10.1007/s10194-009-0163-x

Prevention of episodic migraines with topiramate: results from a non-interventional study in a general practice setting

Gereon Nelles 1,7,✉, Lukas Schmitt 2, Thomas Humbert 3, Veit Becker 3, Petra Sandow 4, Karin Bornhoevd 5, Dirk Fritzsche 6, Barbara Schäuble 5; on behalf of the TOPMATMIG-0001 investigators
PMCID: PMC3452185  PMID: 19894100

Abstract

The majority of patients with migraine headaches are treated in non-specialized institutions though data on treatment outcomes are largely derived from tertiary care centers. The current non-interventional study explores efficacy and tolerability outcomes of patients with episodic migraines receiving topiramate as preventive agent in a general practice setting. A total of 366 patients (87% female, mean age 41.8 ± 11.6 years) were eligible for migraine prevention and treated with flexible dose topiramate for 6 months (core phase), and optionally for a total of 12 months (follow-up phase). Overall, 261 patients (77.7% of safety analysis set, SAF) completed the core phase. Reasons for discontinuation included adverse events (2.1%), lost to follow-up (1.8%), other reasons (1.5%), and end of therapy (0.3%) though in the majority of patients who discontinued no reasons were listed. The median daily dose at endpoint was 50 mg/day (range, 25–187.5 mg/day). The median days with migraine headaches decreased from 6.0 to 1.2 days (p < 0.001), median pain intensity score decreased from 17.0 to 3.2 points (p < 0.001). In women with reported menstruation-associated migraine, the median number of migraine attacks decreased from 4.0 to 0.9 (p < 0.001). Absenteeism as well as triptan use decreased significantly, and significant improvements in activities of daily living and quality of life were reported. The most frequently reported AEs were paraesthesia (4.2%) and nausea (3%). Results suggest that migraine prevention with topiramate in a general practice is generally well tolerated and associated with a significant improvement in migraine headaches and related functional impairment.

Keywords: Migraine prevention, Topiramate, Open label study, Menstruation

Full Text

The Full Text of this article is available as a PDF (411.2 KB).

Acknowledgments

We thank the study coordinators from Janssen-Cilag, Germany for their contribution and Kerstin Schuppien and Tanja Hendrichs, PhD, for editorial assistance with the manuscript.

Conflict of interest

Dr. Bornhoevd and Dr. Schauble are full time employees of Janssen-Cilag EMEA, Neuss, Germany. The study was conducted by Medidata, Konstanz, Germany and Dr. Fritzsche served as a consultant for the statistical analysis. The study has been sponsored by Janssen-Cilag Germany.

Glossary

AE

Adverse event

CRF

Case report form

CP

Core phase

EAS

Efficacy analysis set

FUAS

Follow up analysis set

EFF

Efficacy population

HIT

Headache impact test

IHS

International headache society

IQR

Interquartile range

LOCF

Last observation carried forward

SAF

Safety population

SD

Standard deviation

Appendix

We gratefully acknowledge the participation of following TOPMAT-MIG-0001 investigators: Thomas Wegner, Königstein; Hans Werner Fischer, Friedrichsthal; Bernhard Wolfram, Mannheim; Karin Schindlbeck, Parsberg; Susanne Peters, Dortmund; Ursula Schax, Essen; Eva M. Dietz, Bamberg; Juergen Haas, Nürnberg; Markus Föh, Fulda; D. Katholnigg, Mönchengladbach; Gerd Rauch, Bayreuth; Martin Kühn, München; Veit-Ulrich Becker, Hamburg; Michael Springer, Pirmasens; Guido M. Auner, Lüdenscheid; Kristin Hontzek, Dommitzsch; Heinz-Wilhelm Kaune, Lohfelden; Volker Schreibmüller, Barsinghausen; Svetlana Liadski, Essen; B. Wiedeking, Essen; Michael Rengeling, Petershagen; Volker Henning, Oberdorla; Barbara Walaschewski, Grabowhöfe; Roland J. Schätzl, Großheirath; Barbara Steinbrück, Stuttgart; Henner Reineke, Stuttgart; Sven Rönnebeck, Hedersleben; Tobias Armbruster, Heilbronn; Roland J. Schätzl, Ebersdorf; Anke Tiedt, Claußnitz; Tim Hördt, Bielefeld; Frank Eisenkrätzer, Radebeul; Rainer Waldmann, Stuttgart; Petra Sandow, Berlin; Bernd Metzger, Stuttgart; Anja Eckert, Leipzig; Nader Kayali, Dorsten; Michael Lang, Ulm; Harald Klein, Darmstadt; Hilmar Böneke, Lienen; Christoph Schiel, Giessen; Matthias Eyck, Berlin; Hans-Dieter Gross, Limburg; Andreas Beck, München; Bernd Spengruber, Wangen im Allgäu; Markus Schulz-Meentzen, Bremen; Arnulf Gruber, Brensbach; Andrea Rubbel-Ehle, Niebuell; Bernd Porrmann, Baden-Baden; Marius Unger, Giengen an der Brenz; Klaus-Peter W. Schaps, Wilhelmshaven; Helmut Stienker-Fisse, Remscheid; Gabriele Meyer, Berlin; Alexander Matuschke, Weyhe; Heike Eckardt, Gütersloh; Ursula Jansen, Pulheim; Katy Klook, Rostock; Mirko Witteborn, Halberstadt; Theresia Roidl, Schwandorf; Katharina Farke-Rämer, Berlin; Michael Dietlein, Augsburg; Peter Möller, Marl; Winfried Hofmann, Marburg; Suso Lederle, Stuttgart; Frank Wiedemann, Kandern-Wollbach; Ursula Rieser, Bärnau; Martin L.J. Wimmer, München; Christa Enderle, Riedlingen; Detlef Gottesbüren, S.gmünd; Thomas Weber, Haren; Manfred Oberling, Bad Camberg; Werner Flöhl, Paderborn; Nenad Martinovic, Eheine; Wolfgang Köller, Berlin; Bärbel Jersch, Schönebeck; Heidrun Adam, Rostock; Olaf Carstensen, Eckernförde; Kerstin Franke, Berlin; Norbert Martini, Gechingen; Hildegard Schneider-Nutz, Köln; Eberhard Bek, Langenbrettach; Birgit Magnus-Ellenbroek, Emmerich: Borries Kukowski, Göttingen; Uwe Jorns, Trossingen; Tatjana Kelch, Dresden; Günther Endrass, Grünstadt; Rainer Katzfuss, Sommerhausen; Lukas Schmitt, Hamburg; Frank Kühn, Oranienburg; Hanns-Joachim Schietsch, Augsburg; Hans D. Diery, Butzbach; Doris Wiese-Junginger, Planegg; Freia Guse-Grosse, Jülich; Jens Thonack, Greifswald; Peter Franz, Berlin; Regina Dauwe, Ettlingen; Uwe Gerbaulet, Löhne; Sabine Koller, Saerbeck; Eva Freitag, Berlin; Reinhard Krug, Ulm; Berthold Jonas, Essen; Alfons Linke, Tübingen; Achim Ulmer, Ludwigsburg; Sigmund Jakob, Weinsberg; Volker Gillwald, Mönchengladbach; Mario Tomm, Heek; Nikolaos Ampatziadis, Wiesbaden; Josip Udosic, München; Christa Koßler-Wiesweg, Essen; Knut-Olaf Brose, Syke; Hans-Peter Westfal, Göttingen; Radu Dan Noveanu, Leonberg; Cornelia Jacob, Lippersdorf; Vilém Fuchs, Köln; Axel Althen, Hainburg; Andreas Lang, Wilhelmshaven; Rupert Lebmeier, Zweibrücken; Karl Friedrich Beykirch, Frankfurt; Steve Müller, Güglingen; Gerhard Krehan, Graben-Neudorf; Robert Ivancic, Gersthofen; Andrea Eichhorn, Wadgassen; Felix Lion, Volkmarsen; Arkadius Misera; Düsseldorf; Christian Nowack, Durmersheim; Andre Wagner, Teutschenthal; Manfred Böger, Castrop-Rauxel; Stefan Ries, Erbach; Klaus Hachenberg, Gütersloh; Peter Pickert, Frankfurt; Marianne Lang, Neckargemünd; Volker Strick, Köln; Anneliese Lüdtke, Neu-Ulm; Maria Siemer, Haselünne; Sinta Setiawan, Nordhorn; Gabriele Feuerstack, Heikendorf; Axel Müller, Magdeburg; Senta Kim-Giesemann, Friesoythe; D. Noack, Limburgerhof; Barbara Unsorg, Erbach; Rainer Busch, Münchweiler; Klaus Weischer, Rheine; Christoph Stenzel, Köln; Christian Albrecht, Hasbergen; Ulrich Assmann, Weil am Rhein; Maria Wegner, Viernheim; Holger Hufnagel, Neckarbischofsheim; Marco Loddo, Rastede; Lutz-Dieter Lohse, Dresden; Wolfgang Derissen, Mönchengladbach; Bernd Junge, Uttenreuth; Frank Seidel, Wiefelstede; Harald Bannies, Solingen; Imke Hanoldt, Stolberg; Rainer Bachus, Berlin; Eva Burger-Deinerth, Berlin; Hoang Ha-Phuoc, Olpe; Memet Gülbeyaz, Hamburg; Gunter Brauer, Cottbus; Wolfgang Leps, Berlin; Faizurrahman Ahrari, Hamburg; Stephan Lode, Hückeswagen; Christian Brandt, Gronau; Rolf Zimmermann, Dessau; Andreas Böhme, Delitzsch; Markus Bruckhaus-Walter, Herne; Udo Phillipp, Berlin; Ulrich Loel, Salzgitter; Michael Bruch, Herne; Kerstin Schulze, Norderstedt; Steffen Christian Kohl, Dessau; Reinhard Lakony, Berlin; Marion Nesimi, Wildau; Hans-Dieter Zug, Böblingen; Serena Scarel, Unterhaching; Ulrich G. Schultheiß, Sigmaringen; Sibylle Berdermann-Welz, Altenburg; Walter Freudenstein, Braunschweig; Regine Schmitt, Nußbach; Angelika Christopher, Berlin; Uwe Patzelt, Seelow; Doris Augustin-Reuss, Solingen; Karl-Otto Sigel, Unterhaching.

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