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A double-blind, dose comparison study of topiramate for prophylaxis of basilar-type migraine in children: a pilot
1Division of Pediatric Neurology, Department of Pediatrics, Children's Hospital of the King's Daughters, Eastern Virginia Medical School, Norfolk, VA 23507-1972, USA.
Insights
Topiramate effectively reduced migraine frequency in children and adolescents with basilar-type migraine (BM). Both 25 mg and 100 mg doses showed significant improvements in BM attack rates and overall migraine reduction.
Area of Science:
- Neurology
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Basilar-type migraine (BM) is a common migraine variant in children, characterized by neurological symptoms preceding headache.
- BM accounts for 3-19% of childhood migraines and significantly impacts quality of life.
Purpose of the Study:
- To evaluate the efficacy and safety of topiramate for preventing basilar-type migraine in pediatric patients.
- To compare the effectiveness of two different topiramate dosages (25 mg and 100 mg) for BM prophylaxis.
Main Methods:
- A 12-week, outpatient, double-blind, randomized, dose-comparison study.
- Participants (6-18 years) with at least 4 BM attacks per month received either 25 mg or 100 mg of topiramate daily.
- Efficacy assessed by reduction in migraine frequency, duration, and disability.
Main Results:
- Both topiramate doses significantly reduced monthly migraine rates (64.4% for 25 mg, 75.0% for 100 mg) and BM attack frequency (74.24% for 25 mg, 82.8% for 100 mg).
- Overall BM attack reduction was 79.2%. 86% of patients experienced >50% reduction in migraine frequency.
- Migraine disability significantly decreased, with no serious adverse events reported.
Conclusions:
- Topiramate is an effective preventive therapy for basilar-type migraine in children and adolescents.
- Both 25 mg and 100 mg doses demonstrated comparable efficacy in reducing migraine frequency and BM attacks.
Background:
Basilar-type migraine (BM) is the most common migraine "variant," representing 3-19% of migraine in children.BMis characterized by attacks of dizziness, vertigo, visual disturbances, ataxia, and/or diplopia, followed by migraine headache.
Objective:
The objective of this study is to assess the efficacy and safety of topiramate for prophylaxis of BM in children and adolescents (6-18 years).
Design:
Outpatient, double-blind, parallel-group, dose comparison study with 2 phases: prerandomization (screening/washout and 4-week prospective baseline) and 12-week double blind (titration and maintenance).
Methods:
Following consent and assent, subjects with BMs, as defined by the International Classification of Headache Disorders (second edition), and > or =4 migraines/month were randomized to receive either 25 mg per day or 100 mg per day of topiramate in a 1 : 1 ratio.
Results:
Fourteen children (4 boys, 10 girls) completed the double-blind phase (7 in the 25-mg group and 7 in the 100-mg group). During the prospective baseline, the mean headache frequency of the combined group "all migraines" per month was 4.5/month (25 mg) and 4.8/month (100 mg). Average duration of migraine was 5.5 hours (25 mg) and 5.0 hours (100 mg) and average mean pain (5-point faces scale) was 3.3 for both (25 mg 100 mg). The reduction in median monthly migraine rate during the double-blind treatment phase relative to baseline was 2.9 (64.4%) and 3.6 (75.0%) for the 25-mg and 100-mg topiramate-treated groups, respectively (P < .001). The reduction in median monthly BM rate during the double-blind treatment phase relative to baseline was 2.5 (74.24%) and 2.3 (82.8%) for the 25-mg and 100-mg topiramate-treated groups, respectively. The overall reduction in BM attacks reduced from 2.84/month to 0.59/month (79.2%; P < .0042). Overall, 86% of patients responded with a greater than 50% reduction in migraine frequency (100%, 25 mg and 71%, 100 mg). Mean reduction in migraine duration was 18 minutes (25 mg) and 89 minutes (100 mg). There was no significant difference in migraine severity between the 2 groups. Parent Global Assessment was "very much" or "much improved" in 6 of 7 (25 mg) and 3 of 7 (100 mg) patients. Migraine disability as measured by PedMidas reduced from moderate to no disability (P < .001). There were no serious adverse events.
Conclusions:
Preventive therapy with topiramate resulted in reducing the overall migraine frequency and the frequency of attacks of BM at both 25 mg and 100 mg doses relative to the historical baseline and prospective baseline periods. The 2 treatment groups resulted in comparable outcomes.
