An open label trial of topiramate as add-on therapy for Malaysian children with inadequately controlled epilepsy

Objectives: To evaluate the efficacy and safety of topiramate as adjunctive therapy in children with inadequately controlled epilepsy. Methods: Children, aged 1-15 years, with inadequately controlled epilepsy were entered into the trial. Topiramate was prescribed at doses of 19 mg/kg/day for 6 months. Primary efficacy variable was the percent reduction in the seizure rate during the maintenance treatment phase. Secondary efficacy evaluation included percentage of patients with >50%, >75% and 100% reduction in seizure rate and pediatricians’ and parental clinical global evaluation. Safety evaluations were performed by monitoring of adverse events and laboratory tests. Results: 40 children with a median age of 7 years were recruited. Median Topiramate dosage at endpoint was 5 mg/kg/day. The median percentage reduction in seizure rate was 66 %. Twenty four (60%) had >50% seizure reduction, 13 (32.5 %) had >75% seizure reduction and 4 (10%) became seizure free. Investigators’ global evaluation at endpoint indicated 7 (17.5%) of the children had a good outcome while parental assessment indicated good response in 9 (22.5 %) of the children. The most common adverse events were anorexia (42.5%), somnolence/lethargy (32.5%) and fever/upper respiratory infections (22.5%), but these were largely transient. Four (10%) patients discontinued the study due to poor seizure control and concomitant adverse events. Conclusion: Topiramate appears to be efficacious and safe in children with a wide variety of refractory seizures. Neurol J Southeast Asia 2003; 8 : 97 – 102 Address correspondence to: Professor Dr. Ong Lai Choo, Department of Paediatrics, Hospital UKM, Jalan Yaacob Latif, Bandar Tun Razak, 5600 Cheras, Kuala Lumpur, Malaysia. INTRODUCTION Epilepsy is a common disorder in children. While the long term prognosis of most children are good, up to 20% are considered to be refractory to treatment, even in developed countries with many approved antiepileptic drugs (AEDs) and several non-pharmacologic options available.1 Topiramate is a novel AED with multiple modes of action. Randomized controlled studies have demonstrated efficacy of topiramate as adjunctive therapy in children with partial seizures2, generalized tonic-clonic seizures3 and Lennox-Gastaut syndrome.4 A study in Asian adult patients with partial epilepsy demonstrated efficacy and safety, quoting lower doses than those recommended in Western countries.5 This study was undertaken to assess the efficacy, safety and doses required to attain seizure control in Malaysian children with diverse forms of severe epilepsy. METHODS