Results from two large clinical trials demonstrate that patients with frequent migraine who were treated with TOPAMAX(R) (topiramate) for up to 14 months (6 months double blind followed by 8 months open label) had a persistent reduction in the frequency of migraine headaches.1 In addition, analyses from the three 26-week placebo-controlled pivotal trials of topiramate in migraine prevention showed that topiramate improves health-related quality of life (HRQoL).2 These data were presented today at the ninth congress of the European Federation of Neurological Societies (EFNS), 17-20 September 2005, in Athens, Greece.

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Efficacy and tolerability results presented from the 8 month open-label extension (OLE) phases of two (*) pivotal, 6-month, randomised, double-blind (DB), placebo-controlled trials with topiramate, demonstrated there was persistent reduction in monthly migraine frequency that was consistent with the initial 6-month maintenance period (100mg/d topiramate change from baseline; -2.5 by end of DB phase, and -3.7 by end of OLE phase).1

A separate analysis of the three pivotal, 26-week, randomised, double-blind, migraine prevention trials with topiramate highlighted that 100 mg/d significantly improved health-related quality of life for patients with migraine for up to six months following initiation of treatment.2 HRQoL was evaluated via a Migraine-Specific Questionnaire (MSQ) which measured the degree to which migraine limited and interrupted patients' daily performance, and via the SF-36 which assess the impact of general medical disorders on HRQoL.

Significant improvement in MSQ scores were observed for all domains as early as week 8 and at every time point thereafter. Topiramate-associated improvements on SF-36 subscales were seen for physical functioning, bodily pain, vitality, general health perceptions, and social functioning compared with placebo.

Dr Domenico D'Amico from the Neurological Institute C. Besta in Milan (Italy), commented: "While acute treatments can lessen the symptoms of a migraine attack once it has started, these trials show that using topiramate as preventative therapy reduces the frequency of migraine attacks. These results offer new hope for patients with frequent migraine in terms of controlling their condition and bring them one step closer to leading a normal, healthy life."

Benefits of preventative therapy were also reinforced when a pooled analysis of the three pivotal trials found that 46.3% of patients on topiramate 100 mg/d achieved at least 50% reduction in the number of monthly migraine periods compared with 22.8% on placebo (p