Topiramate in migraine prophylaxis: a randomised double-blind versus placebo study

Abstract

The objectives of this paper are to evaluate the efficacy and tolerability of topiramate, given at the dose of 100 mg/day, in the prophylactic treatment of migraine. The hypothesis that migraine is the result of a condition of neuronal hyperexcitability and the quest for drugs that are able to limit the number of crises justifies the attempt to utilise the new antiepileptic drugs in the prophylaxis of this pathology, which is so important due to its high prevalence and due to the high disability it causes. The study was randomised double-blind versus placebo, lasting 16 weeks, and was preceded by a run-in period of 4 weeks. One hundred and fifteen patients were randomly allocated to treatment with topiramate (TPM) or placebo: 35 patients completed the study in the TPM group and 37 patients in the placebo group. At the end of the double-blind phase of study, in the TPM group, we recorded a significant reduction in the frequency of migraine crises (from 5.26 at baseline to 2.60 in the last 4 weeks), a significant reduction in the quantity of symptomatic drugs taken as compared to the placebo control group (from 6.17+/-1.80 SD to 2.57+/-0.80) and a significant downward trend in the number of days of disability over the 16-week period of therapy. In the TPM group, side effects were transient and well tolerated. TPM has thus proven its efficacy and tolerability in the prophylaxis of migraine.

Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults

“…19 -25 Four studies demonstrated significant improvement over placebo 19,20,23,24 ; one included an active comparator arm, suggesting equivalence of topiramate (100, 200 mg/day) and propranolol (160 mg/day). 20 Two studies comparing topiramate and amitriptyline (25-150 mg/day) reported no difference in efficacy for primary endpoints; however, amitriptyline was associated with a significant AE increase, and the amitriptylinetopiramate combination suggested improvement in depression scores vs monotherapy.…”

Systematic Review of Migraine Prophylaxis Adherence and Persistence

“…Four open-label studies were identified that evaluated topiramate [21][22][23] or amitriptyline alone, 24 while 2 comparative studies evaluated divalproex and topiramate, 25 and flunarizine and propranolol. 26 Studies were conducted in Germany, [21][22][23] Austria, 24 Belgium, 26 the Netherlands, 27 and Brazil.…”

“…26 Studies were conducted in Germany, [21][22][23] Austria, 24 Belgium, 26 the Netherlands, 27 and Brazil. 25 Dosages varied by individual patient but were within the range of approved FDA-labeled dose for migraine prophylaxis, where applicable.…”

The Pharmacotherapy of Chronic Pain: A Review

“…Several randomized, placebo-controlled trials examining topiramate in the treatment of migraine prophylaxis have demonstrated a statistically significant reduction in the frequency of migraine headaches with topiramate compared with placebo (132)(133)(134)(135)(136)(137)(138). Doses have ranged from 50 mg/day to 200 mg/day.…”