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Headache Drugs: Topamax (Topiramate)

Favorable Response of Trigeminal Neuralgia to the Anticonvulsant Topiramate: A Retrospective Study
M.J. Haugh, Cephalalgia, May 2000

To perform a retrospective analysis of patients treated with topiramate for trigeminal neuralgia. A retrospective chart review identified eight patients aged 40-79 years (seven female, one male) who had been treated with topiramate for 1-20 months for trigeminal neuralgia.

The results in this small group of patients suggest topiramate has efficacy in the treatment of trigeminal neuralgia. Further study is warranted in double-blind, placebo-controlled trials.

Topiramate (Topamax) for Migraine Prophylaxis: A Double-Blind, Randomized, Placebo-Controlled Study

To determine the efficacy and safety of topiramate in migraine prophylaxis.

Antiepileptic medications are taking an increasing role in the prophylaxis of migraine headache. Preliminary observations with topiramate, a broad-spectrum anticonvulsant, suggest it may provide benefit in prevention of episodic migraine.

Design and Methods:
Thirty patients aged 18 to 65 years with an IHS diagnosis of migraine with or without aura were randomized to topiramate (n=15) or placebo (n=15) after completing a 4-week baseline phase. Patients were titrated over 6 weeks by 25-mg. increments to a maximum dose of 100 mg. bid followed by a 12-week maintenance phase. The primary efficacy analysis was comparison of 28-day migraine frequency during the double-blind period for all patients randomized. Secondary efficacy analysis included comparison of 28-day frequency for patients with data during the last 10 weeks of the study, and comparison of 50% response rates in each group over the entire double-blind period.

There was a statistical trend towards a lower 28-day migraine frequency in the topiramate group compared to the placebo group during the entire double-blind phase (3.00 ± 2.60 vs. 3.78 ± 1.99; p=0.10).

The 50% responder rate was significantly higher in the topiramate vs. placebo group (46.7% vs. 6.7%, p=0.035). The most common adverse events in the topiramate group were paresthesia, diarrhea, altered taste, and somnolence. Seven patients on topiramate discontinued from the study, 4 due to adverse events and 3 for other reasons. Six patients on placebo discontinued from the study, 3 due to lack of efficacy and 3 for other reasons.

These results suggest that topiramate has efficacy in the prophylaxis of migraine headache. Further study is warranted in larger, placebo-controlled, multicenter trials.