Objective: To evaluate the efficacy and safety of adjunctive topiramate (sprinkle capsules or oral liquid) in reducing daily rates of partial-onset seizures (POS) in infants with refractory POS. Methods:In this double-blind, placebo-controlled, parallel-group, international study, infants (n ϭ 149) with clinical or EEG evidence of refractory POS were randomly allocated (1:1:1:1) to receive adjunctive topiramate 5, 15, or 25 mg/kg/d or placebo for 20 days. The primary variable was the median percentage reductions in daily POS rate from baseline to final assessment as recorded on a 48-hour video-EEG. Results:Of the 149 infants (mean age 12 months) included in the intent-to-treat analysis set, 130 completed the study. Median percentage reduction from baseline in daily POS rate was not significantly different (p ϭ 0.97) between topiramate 25 mg/kg (20.4%) and placebo (13.1%). Lower doses were not formally tested, but nominal p values for comparisons with placebo were not significant (15-mg/kg/d dose: p ϭ 0.97; 5-mg/kg/d dose: p ϭ 0.91). Treatment-emergent fever, diarrhea, vomiting, anorexia, weight decrease, somnolence, and viral infection occurred more frequently (Ն10% difference) with topiramate than with placebo. The incidence of newly diagnosed epilepsy is highest in the first year of life and includes many syndromes that are unique and are difficult to diagnose and classify. Conclusion:1,2 Also, seizure types and epilepsy syndromes evolve with age, making accurate diagnoses difficult or retrospectively incorrect in up to 25% of cases. 3,4 Contributing to the treatment challenges, many randomized controlled trials of newer antiepileptic drugs (AEDs) did not assess efficacy in children, and most available AEDs have not been rigorously investigated in infants, leaving physicians with incomplete data on which to base treatment decisions.5 A sizeable number of epilepsy syndromes are significantly different from those in adults. Therefore, clinical trial design in this population requires careful evaluation and must be different from adult trials.6 Drug dosing is also more difficult in children and often requires adjustment as the child matures. e-Pub ahead of print on January 20, 2010, at www.neurology.org. Investigators and institutions at which trials were performed are listed in appendix e-1 on the Neurology ® Web site at www.neurology.org.
Cerebral sinus vein thrombosis is rare in children. So far, only three other cases have been reported in a child with diabetes mellitus. This 10 year-old female presented with classic signs of diabetic ketoacidosis which resolved with standard fluid and insulin therapy. Headache persisted despite biochemical improvement and 6 th nerve palsy became evident on Day 3. On Day 5, sudden deterioration in mental status to the point of coma with loss of airway protective reflexes prompted repeat imaging including magnetic resonance venography which demonstrated thrombosis of the superior sagittal, straight, right transverse, right sigmoid and proximal posterior aspect of the left transverse sinuses. Selective thrombolysis using rTPA was performed emergently. Complete lysis of the thrombosed veins was observed within 35 hours. Low molecular weight heparin was continued for 6 months. Significant clinical improvement was noted within 48 hours of the procedure. Six weeks later recovery was complete. Complete hematological work-up for hypercoagulable state revealed a heterozygous mutation of the prothrombin gene (G20210A). Children with this mutation are generally asymptomatic unless challenged by a second risk factor, in this case by severe dehydration and diabetic ketoacidosis.Our patient presented a unique diagnostic challenge at the time of her acute neurological deterioration. Rapid, aggressive intervention with super-selective thrombolysis resulted in complete resolution of severe and potentially life devastating neurological symptoms.
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