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Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial
Paul Winner1, Eric M Pearlman, Stephen L Linder
1Palm Beach Headache Center/Palm Beach Neurology, West Palm Beach, FL 33407, USA.
Insights
Topiramate may effectively reduce monthly migraine days in children. This pilot study found topiramate well-tolerated, suggesting its potential as a pediatric migraine preventive therapy.
Area of Science:
- Neurology
- Pediatric Medicine
- Clinical Pharmacology
Background:
- Limited treatment options exist for pediatric migraine prevention in the US.
- Topiramate is an established effective migraine preventive therapy for adults.
Purpose of the Study:
- To evaluate the efficacy and safety of topiramate for preventing pediatric migraine.
- To compare topiramate's effectiveness against a placebo in children aged 6-15.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 162 children with migraine.
- Participants received either topiramate (titrated up to 200 mg/day) or placebo for a maintenance period of 12 weeks.
- The primary outcome was the change in mean monthly migraine days from baseline.
Main Results:
- Topiramate showed a trend towards greater reduction in migraine days (2.6 vs. 2.0 days/month, P=.061).
- A significantly higher proportion of topiramate patients (32%) achieved ≥75% reduction in migraine days compared to placebo (14%, P=.02).
- Adverse event discontinuation rates were low (6.5% for topiramate, 4.0% for placebo).
Conclusions:
- Topiramate demonstrates potential as an effective migraine preventive therapy in children.
- The medication was generally well-tolerated in the pediatric population studied.
- Further randomized studies are needed to confirm efficacy for pediatric migraine prevention.
Objective:
To assess the efficacy and safety of topiramate for the prevention of pediatric migraine with or without aura in a double-blind, randomized, placebo-controlled trial.
Background:
Treatment options for pediatric migraine are currently limited, and no migraine preventive agents are approved for use in children in the United States. Topiramate is an effective migraine preventive therapy in adults, as demonstrated in several large, randomized, placebo-controlled trials.
Methods:
One hundred and sixty-two children with migraine (age, 6 to 15 years) were randomized in a 2:1 ratio to receive topiramate (n = 112) or placebo (n = 50). This study was designed to ensure that 150 participants were randomized to study medication. An additional 12 qualified patients were randomized because they had successfully completed the screening phase. The double-blind phase of the trial consisted of a titration period and a maintenance period. Topiramate was initiated at 15 mg/day and titrated over 8 weeks to 2 to 3 mg/kg per day, or maximum tolerated dose, whichever was less (maximum allowed dose was 200 mg/day). The target dose was maintained for 12 weeks. The primary efficacy variable was the change in mean number of migraine days per month (28 days) during the double-blind phase relative to the 4-week prospective baseline phase for each treatment group.
Results:
Topiramate treatment was associated with a mean reduction over the entire double-blind phase of 2.6 migraine days per month, compared with a mean reduction of 2.0 migraine days per month for placebo (P = .061 topiramate vs. placebo). A significantly greater percentage of topiramate patients (32%) experienced a > or = 75% reduction in mean monthly migraine days compared with placebo (14%, P = .02). Discontinuation rates due to adverse events were low: 6.5% for the topiramate group and 4.0% for the placebo group. The adverse events that occurred most commonly in the topiramate group at an incidence rate greater than in the placebo group were: upper respiratory tract infection, anorexia, weight decrease, gastroenteritis, paresthesia, and somnolence. The mean average daily dose of topiramate during the maintenance period was 2.0 mg/kg per day.
Conclusions:
This pilot study suggests that topiramate may be an effective migraine preventive therapy in children. Topiramate was well tolerated in this population. Further randomized studies would be required to definitively establish the efficacy of topiramate for pediatric migraine prevention.
