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Gabapentin as add-on therapy in children with refractory partial seizures: a 12-week, multicentre, double-blind,
R Appleton1, K Fichtner, L LaMoreaux
1Department of Neurology, Alder Hey Children's Hospital, Liverpool, England, UK.
Insights
Gabapentin (GBP) effectively reduced refractory partial seizures in children aged 3-12 years. This add-on therapy demonstrated good tolerability and improved seizure control, particularly for complex partial and secondarily generalized seizures.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Refractory partial seizures in children pose significant treatment challenges.
- Identifying effective add-on therapies is crucial for improving seizure control and patient well-being.
Purpose of the Study:
- To assess the efficacy and safety of gabapentin (GBP) as an adjunctive treatment for drug-resistant partial seizures in pediatric patients aged 3-12 years.
Main Methods:
- A 12-week, double-blind, placebo-controlled trial involving 247 pediatric patients with refractory partial seizures.
- Patients received either GBP (titrated to 23-35 mg/kg/day) or placebo as add-on therapy.
- Efficacy was measured by seizure frequency reduction, responder rates, and global assessments.
Main Results:
- Gabapentin treatment resulted in a statistically significant reduction in the Response Ratio for all partial seizures (p = 0.0407).
- Median percentage change in seizure frequency was notably better with GBP (-17.0%) compared to placebo (-6.5%), especially for complex partial and secondarily generalized seizures.
- Global assessments by parents/guardians indicated a significant improvement in seizure frequency reduction with GBP (p = 0.046).
Conclusions:
- Gabapentin is an effective and well-tolerated add-on therapy for pediatric patients experiencing drug-resistant partial seizures.
- The findings support the use of gabapentin in managing challenging epilepsy syndromes in children.
Purpose:
To evaluate the efficacy and safety of gabapentin (Neurontin; GBP) as add-on therapy for refractory partial seizures in paediatric patients aged 3-12 years.
Methods:
After a 6-week baseline period, 247 patients (54 centres) entered a 12-week double-blind phase and were randomized to receive either GBP (t.i.d., titrated to 23-35 mg/kg/ day) or placebo. Seizure activity and type were recorded daily. Efficacy variables included Response Ratio (RRatio), responder rate, and percentage change in frequency (PCH) for all partial seizures; PCH and RRatio for individual types of partial seizures; and investigator and parent/guardian global assessments of seizure frequency and patient well-being.
Results:
RRatio for all partial seizures was significantly lower (better) for GBP-treated patients (p = 0.0407). Responder rate favored GBP, but the difference between treatment groups was not statistically significant. Median PCH for all partial seizures for the GBP treatment group (-17.0%) was better than that for the placebo group (-6.5%). Median PCH for specific seizure types showed GBP to be most effective in controlling complex partial seizures (-35%) and secondarily generalized seizures (-28%) when compared with placebo (-12%, +13%, respectively). A greater percentage of GBP-treated patients exhibited improvement according to investigator and parent/guardian global assessments, with a statistically significant difference observed in the parent/guardian global assessment of seizure-frequency reduction (p = 0.046). Three GBP patients and one placebo patient were seizure free during the double-blind treatment period. GBP was well tolerated.
Conclusions:
GBP was effective and well tolerated as an add-on therapy for partial seizures in paediatric patients with previously drug-resistant seizures.