Topiramate in migraine prophylaxis (original) (raw)

Abstract.

Topiramate (TPM) has shown efficacy in migraine prophylaxis in two large placebo–controlled, dose–ranging trials. We conducted a randomised, doubleblind, multicentre trial to evaluate the efficacy and safety of two doses of topiramate vs placebo for migraine prophylaxis, with propranolol (PROP) as an active control. Subjects with episodic migraine with and without aura were randomised to TPM 100 mg/d, TPM 200 mg/d, PROP 160 mg/d (active control), or placebo. The primary efficacy measure was the change in mean monthly migraine frequency from the baseline phase relative to the double–blind treatment phase. Five hundred and seventy–five subjects were enrolled from 61 centres in 13 countries. TPM 100 mg/d was superior to placebo as measured by reduction in monthly migraine frequency, overall 50% responder rate, reduction in monthly migraine days, and reduction in the rate of daily rescue medication use. The TPM 100 mg/d and PROP groups were similar with respect to reductions in migraine frequency, responder rate, migraine days, and daily rescue medication usage. TPM 100 mg/d was better tolerated than TPM 200 mg/d, and was generally comparable to PROP. No unusual or unexpected safety risks emerged. These findings demonstrate that TPM 100 mg/d is effective in migraine prophylaxis. TPM 100 mg/d and PROP 160 mg/d exhibited similar efficacy profiles.

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Authors and Affiliations

1. Department of Neurology, University Essen, Hufelandstr 55, 45122, Essen, Germany
   Hans-Christoph Diener
2. Department of Neurology, University of Copenhagen Glostrup Hospital, Glostrup, Denmark
   P. Tfelt-Hansen MD, PhD
3. Gothenburg Migraine Clinic, Gothenburg, Sweden
   C. Dahlöf MD, PhD
4. Department of Neurology, Hospital Clinico Universitario University of Valencia, Valencia, Spain
   M. J. A. Láinez MD, PhD
5. Headache Centre IRCC C. Mondino Foundation, University of Pavia, Pavia, Italy
   G. Sandrini MD
6. Neurological Institute Taipei, Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan
   Sh.-J. Wang MD
7. Johnson & Johnson, Pharmaceutical Research and Development, LLC Raritan, NJ USA
   W. Neto MD, U. Vijapurkar PhD, A. Doyle MD & D. Jacobs MD

Authors

1. Hans-Christoph Diener
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2. P. Tfelt-Hansen MD, PhD
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3. C. Dahlöf MD, PhD
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4. M. J. A. Láinez MD, PhD
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5. G. Sandrini MD
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6. Sh.-J. Wang MD
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7. W. Neto MD
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8. U. Vijapurkar PhD
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9. A. Doyle MD
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10. D. Jacobs MD
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on behalf of the MIGR-003 Study Group

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Correspondence to Hans-Christoph Diener.

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Diener, HC., Tfelt-Hansen, P., Dahlöf, C. et al. Topiramate in migraine prophylaxis.J Neurol 251, 943– 950 (2004). https://doi.org/10.1007/s00415-004-0464-6

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• Received: 02 January 2004
• Revised: 27 February 2004
• Accepted: 08 March 2004
• Issue Date: August 2004
• DOI: https://doi.org/10.1007/s00415-004-0464-6

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