Aktuelle Neurologie 2008; 35 - P475
DOI: 10.1055/s-0028-1086729

Migraine preventive therapy with topiramate reduces the number of migraine auras: results from PROMPT, a randomised, placebo-controlled trial

U Reuter 1, A Gendolla 1, M Sanchez del Rio 1, H.C Diener 1, G Allais 1, J Pfeil 1, S Schwalen 1, B Schäuble 1, J van Oene 1
  • 1Berlin, Essen, Neuss; Madrid, E; Turin, I; Doesburg, Tilburg, NL

Rationale: To evaluate topiramate efficacy for prevention of migraine aura's in addition to migraine headaches.

Methods: After a 4–8-week baseline period, patients entered a 26-week open-label phase (OL); topiramate was titrated from 25 to 100mg/day in weekly 25-mg steps, and could be further adjusted (range: 50–200mg/day). Dosing was kept stable for the last 4 weeks, and patients were randomised to continue this dose (n=254) or switch to placebo (n=258) for 26 weeks in the double-blind phase (DB). Trial subjects recorded the occurrence of migraine auras with or without subsequent migraine headache in a diary. The number of monthly aura days was asssessed for subjects reporting an aura at least once troughout the study, and the change in monthly aura days versus baseline was calculated for the various visits.

Results: 6-month treatment with topiramate was completed by 571/818 entered subjects (70%) who experienced a significant reduction in mean monthly migraine days from 8.86at start to 4.78at month-6 (mean change: -4.08 days; p<0.001)[1]. Migraine auras were reported by 269/818 entered subjects (33%) who experienced a significant reduction in mean monthly aura days from 3.01at start to 1.66at month-6 (mean change: -1.36 days; p<0.001). Topiramate was well tolerated and adverse events were consistent with those previously observed.

Conclusion: Migraine preventive treatment with topiramate resulted in a reduction in monthly aura days similar to the reduction in monthly migraine headache days.

Reference: Diener HC, et al. Lancet Neurology 2007;6:1054–62.