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A double-blind, randomized trial of topiramate as adjunctive therapy for partial-onset seizures in children.
R D Elterman1, T A Glauser, E Wyllie
1Dallas Pediatric Neurology Associates, TX 75230, USA.
Insights
Topiramate effectively reduced partial-onset seizures in children aged 2-16 years. The adjunctive therapy demonstrated safety, with mild to moderate side effects and no study discontinuations due to adverse events.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Epilepsy affects millions of children worldwide.
- Partial-onset seizures are a common form of epilepsy in pediatric populations.
- Effective adjunctive therapies are crucial for managing uncontrolled seizures in children.
Purpose of the Study:
- To assess the efficacy and safety of topiramate as adjunctive therapy for pediatric patients with uncontrolled partial-onset seizures.
- To compare topiramate 6 mg/kg/day against placebo in a randomized, double-blind, controlled trial setting.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial was conducted.
- Participants included children aged 2 to 16 years with at least six partial-onset seizures during an 8-week baseline.
- Patients received either topiramate (n=41) or placebo (n=45) for 16 weeks.
Main Results:
- Topiramate showed a significantly greater median percent reduction in seizure rate (33.1% vs. 10.5%, p=0.034).
- A higher proportion of topiramate patients were responders (≥50% reduction: 39% vs. 20%, p=0.080; ≥75% reduction: 17% vs. 2%, p=0.019).
- Improved parental global evaluations and increased incidence of emotional lability, fatigue, and cognitive difficulties were noted with topiramate.
Conclusions:
- Topiramate is a safe and effective adjunctive treatment for children with partial-onset seizures.
- The benefits of topiramate in seizure reduction outweigh the mild to moderate adverse events observed.
- Further research can explore long-term efficacy and management of side effects in pediatric epilepsy.
Objective:
To evaluate the efficacy and safety of topiramate 6 mg/kg/day in children (age 2 to 16 years) as adjunctive therapy for uncontrolled partial-onset seizures with or without secondarily generalized seizures in a multicenter, randomized, double-blind, placebo-controlled trial.
Methods:
Patients with at least six partial-onset seizures during the 8-week baseline phase were treated with either topiramate (n = 41) or placebo (n = 45) for 16 weeks.
Results:
Topiramate-treated patients had a greater median percent reduction from baseline in average monthly partial-onset seizure rate than placebo-treated patients (33.1% versus 10.5%, p = 0.034), a greater proportion of treatment responders (i.e., patients with a > or = 50% seizure rate reduction; 16 of 41 [39%] versus 9 of 45 [20%], p = 0.080), and patients with a > or = 75% seizure rate reduction (7 of 41 [17%] versus 1 of 45 [2%], p = 0.019), and better parental global evaluations of improvement in seizure severity (p = 0.019). Emotional lability (12% versus 4%), fatigue (15% versus 7%), difficulty with concentration or attention (12% versus 2%), and forgetfulness/impaired memory (7% versus 0%) were more frequent among topiramate-treated than placebo-treated patients. Most treatment-emergent adverse events were mild or moderate in severity. No topiramate-treated patients discontinued the study due to adverse events.
Conclusions:
Topiramate was safe and effective in the treatment of partial-onset seizures in children.