A randomized, one-year clinical trial comparing the efficacy of topiramate, flunarizine, and a combination of flunarizine and topiramate in migraine prophylaxis.
ABSTRACT The objective of this study was to observe the efficacy, safety, and side effects of a combination of flunarizine plus topiramate compared with either flunarizine and or toparamate alone for migraine prophylaxis.
Out of 150 patients with migraine recruited into the study and randomly assigned to one of three conditions, 126 completed the trial in their group: flunarizine (39), topiramate (44), and flunarizine plus topiramate (43). Patient information was assessed at enrollment and at follow-up visits at the end of months 1-3, 6, 9, and 12. The primary measure of efficacy reduction in mean monthly migraine frequency of at least 50% as compared with baseline. Secondary efficacy parameters included reduction in mean monthly migraine days and severity of headache. Side effects were compared in the three groups by recording adverse reactions and weight changes.
The proportion whose monthly headache frequency decreased more than 50% was 66.7% (26/39) in the flunarizine group, 72.7% (32/44) in the topiramate group and 76.7% (33/43) in the combination group, respectively (P=0.593). The mean monthly days and severity of headache in the three groups also declined and was more significant in the flunarizine plus topiramate group than in the flunarizine group and the topiramate group (P<0.05). In the flunarizine group, the average weight change was 0.6kg. Topiramate was associated with a mean weight loss was of -0.9kg in the topiramate group and -0.2kg in the flunarizine plus topiramate group.
Flunarizine, topiramate, and the combination of flunarizine with topiramate are all effective and have good tolerability in migraine prophylaxis. Adding topiramate to flunarizine may reduce the latter's impact on body weight.
- Headache The Journal of Head and Face Pain 07/2005; 45(6):748-50. · 2.94 Impact Factor
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ABSTRACT: To assess the efficacy and safety of low-dose topiramate in migraine prophylaxis vs propranolol. A randomized, double-blind, clinical trial including 62 patients with frequent migraine headaches (> or = 3 attacks per month) was performed for a period of 8 weeks. The patients were randomly divided into two treatment groups - treated by topiramate 50 mg/day and propranolol 80 mg/day, respectively. The patients were assessed at 0, 4, and 8 weeks of the study. Results - The topiramate group showed a reduction in the mean (+/-SD) of monthly migraine frequency from 6.07 (+/-1.89) to 1.83 (+/-1.39) episodes per month, headache intensity from 7.1 (+/-1.45) to 3.67 (+/-2.1) based on the Visual Analog Scale, and headache duration from 16.37 (+/-7.26) to 6.23 (+/-5.22) hours (P < 0.001). In the patients treated with propranolol, the mean (+/-SD) of monthly headache frequency declined from 5.83 (+/-1.98) to 2.2 (+/-1.67) per month, headache intensity lessened from 6.43 (+/-1.6) to 4.13 (+/-1.94) and headache duration decreased from 15.10 (+/-6.84) to 7.27 (+/-6.46) h (P < 0.001). This study demonstrated that both low-dose topiramate and propranolol could significantly reduce migraine headache frequency, intensity, and duration. However, compared with propranolol, low-dose topiramate showed better results.Acta Neurologica Scandinavica 08/2008; 118(5):301-5. · 2.47 Impact Factor
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ABSTRACT: Familial hemiplegic migraine, an autosomal dominant disorder characterized by attacks of transient hemiparesis followed by a migraine headache, is classically divided into pure familial hemiplegic migraine (affecting 80 percent of families) and familial hemiplegic migraine with permanent cerebellar signs (affecting 20 percent of families). Mutations in CACNA1A, which encodes a neuronal calcium channel, are present in 50 percent of families with hemiplegic migraine, including all those with cerebellar signs. We studied the various clinical manifestations associated with mutations in CACNA1A in families with hemiplegic migraine with and without cerebellar signs. CACNA1A was analyzed and nine mutations were detected in 15 of 16 probands of families affected by hemiplegic migraine and cerebellar signs, in 2 of 3 subjects with sporadic hemiplegic migraine and cerebellar signs, and in 4 of 12 probands of families affected by pure hemiplegic migraine. Genotyping of probands and relatives identified a total of 117 subjects with mutations whose clinical manifestations were assessed in detail. Eighty-nine percent of the subjects with mutations had attacks of hemiplegic migraine. One third had severe attacks with coma, prolonged hemiplegia, or both, with full recovery. All nine mutations, including five newly identified ones, were missense mutations. Six mutations were associated with hemiplegic migraine and cerebellar signs, and 83 percent of the subjects with these six mutations had nystagmus, ataxia, or both. Three mutations were associated with pure hemiplegic migraine. Hemiplegic migraine in subjects with mutations in CACNA1A has a broad clinical spectrum. This clinical variability is partially associated with the various types of mutations.New England Journal of Medicine 08/2001; 345(1):17-24. · 51.66 Impact Factor