A pilot study of topiramate in childhood absence epilepsy.

OBJECTIVE: Evaluate the antiepileptic effect of topiramate monotherapy in childhood absence epilepsy (CAE). MATERIALS AND METHODS: Childhood absence epilepsy patients aged 4-9 years were initiated with topiramate 15 or 25 mg/day, which was titrated upwards until patients were free of absence seizures. The primary efficacy outcome was seizure-free rates after a 12-week maintenance period. RESULTS: The study was terminated early due to lack of efficacy after enrollment of 12 patients. Four patients completed the study; two became clinically seizure-free, but without a significant reduction in the number of electrographic seizures. Six patients discontinued for lack of efficacy, none due to adverse events (AEs). Mean reduction in seizure count was seen on Days 22 (P = 0.0391) and 36 (P = 0.0156) and percentage of days with seizures decreased from baseline. Most AEs were mild. CONCLUSIONS: Although well-tolerated, this pilot study did not demonstrate an antiepileptic effect of topiramate monotherapy for treatment of CAE.

Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months.

OBJECTIVE: This randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy and tolerability of adjunctive lamotrigine for the treatment of partial seizures in infants aged 1 to 24 months. METHODS: The study used a responder-enriched design in which all patients received adjunctive lamotrigine during an open-label phase (n = 177; maximum maintenance dose 5.1 mg/kg/day for those on non-enzyme-inducing antiepileptic drugs [AEDs] or valproate and 15.6 mg/kg/day for those on enzyme-inducing AEDs). Patients meeting response criteria were randomly assigned to double-blind treatment for up to 8 weeks with continued lamotrigine (n = 19) or to withdrawal from lamotrigine (placebo; n = 19) while background AEDs were maintained. RESULTS: The proportion of treatment failures (patients who met escape criteria or withdrew before completing the double-blind phase) was lower with lamotrigine (58%) than with placebo (84%). This finding was not significant in the primary analysis (two-sided chi(2) test [primary endpoint]). A post hoc sensitivity analysis of the primary endpoint was also performed (p = 0.045 by one-sided, mid-p corrected Fisher exact test). The median time to meet escape criteria was longer with lamotrigine (42 days) than with placebo (22 days) (p = 0.059). During the last 28 days of the open-label phase, 53% of the patients had a >or=50% reduction in frequency of partial seizures with lamotrigine. Additional reduction in partial seizure frequency was observed during the double-blind phase compared with the last 4 weeks of the open-label phase among those randomly assigned to lamotrigine (32% with a >or=25% reduction) but not those randomly assigned to placebo (5% with a >or=25% reduction). Lamotrigine was well tolerated, with an adverse event profile comparable to that observed in older pediatric patients. CONCLUSION: Lamotrigine was well tolerated, and the data indicate that it may be efficacious in the treatment of partial seizures in infants aged 1 to 24 months.

Oxcarbazepine adjunctive therapy in infants and young children with partial seizures.

OBJECTIVE: To evaluate the efficacy, safety, and pharmacokinetics of oxcarbazepine as adjunctive therapy in infants and young children (1 month to < 4 years). METHODS: Children 1 month to < 4 years of age with inadequately controlled partial seizures taking up to two concomitant antiepileptic drugs (AEDs) were enrolled in this rater-blind, randomized, parallel-group study. Patients received either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) oxcarbazepine as oral suspension. The primary efficacy variable was the absolute change in electrographic partial seizures with a behavioral correlate (type 1 seizure) frequency per 24 hours during the last 72 hours of continuous video-EEG monitoring in the treatment phase compared with baseline seizure frequency. RESULTS: Of 191 patients screened, 128 were randomized: 64 to both oxcarbazepine dose groups. The median absolute change in type 1 seizure frequency per 24 hours was more effective for the high-dose group (-2.00) compared with the low-dose group (-1.37; p = 0.043). The median percentage reduction in type 1 seizure frequency per 24 hours was also greater in the high-dose group (83.33%) than in the low-dose group (46.18%; p = 0.047). The most frequent adverse events (> or = 10%) were somnolence and pyrexia, and most were mild in severity. CONCLUSIONS: In this study, high-dose oxcarbazepine was significantly more effective than low-dose oxcarbazepine in controlling partial seizures in infants and very young children.

Analgesic-induced headaches in a 17-month-old infant.

This is a case report of a 17-month-old infant with 8 weeks of constant headache, which resulted from the daily ingestion of analgesics.

Pediatric manifestations of Hashimoto's encephalopathy.

Hashimoto's encephalopathy is a steroid-responsive encephalopathy associated with elevated blood concentrations of antithyroid antibodies. The patients are usually euthyroid or mildly hypothyroid. The authors report two pediatric patients with Hashimoto's encephalopathy and review the literature. The clinical picture in adolescents, as with adults, is pleomorphic but frequently associated with seizures, confusion, and hallucinations. Alternatively, progressive cognitive decline manifested by a drop in school performance can be observed. The diagnosis of Hashimoto's thyroiditis is often overlooked at presentation and a high degree of suspicion is necessary for proper diagnosis.

Analgesic rebound headache in children and adolescents.

For more than a decade, the frequent use of analgesics has been recognized to lead to daily headaches in adults. To date, no studies on the occurrence of analgesic rebound headache have been done on the pediatric population. We retrospectively reviewed all charts of patients with the diagnosis of headache seen in our pediatric headache clinic between January 1996 and May 1997. Among the 98 patients seen, 46 (47%) suffered from daily or near daily headaches; 30 of them were consuming daily analgesics. Twenty-four patients (mean age 12.1 years, and mean follow-up 6.2 months) successfully discontinued their analgesics. Twenty-two patients were also placed on amitriptyline. A significant reduction in the frequency (80%), severity (47%), and number of school days missed (74%) were seen. In conclusion, this data is comparable to previous observations reported in adults, and suggests that the daily use of analgesics might result in daily or near daily headaches in the pediatric population. Discontinuing daily analgesics, with the concomitant use of amitriptyline, is an effective treatment for analgesic rebound headache in this population.