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Objective: To evaluate the efficacy, safety, and tolerability of carisbamate (CRS), an investigational drug, as adjunctive treatment for partial-onset seizures in adults., Methods: A randomized, double-blind, placebo-controlled, multicenter, dose-ranging study was conducted in 12 countries. Patients counted seizures during an 8-week baseline period, and then, if eligible, entered a double-blind phase consisting of a 4-week dose-titration period (target CRS doses: 100, 300, 800, or 1,600 mg/d or placebo in two divided doses) and a 12-week maintenance period. The primary efficacy variable was percent reduction in partial-onset seizure frequency during the double-blind phase compared with pretreatment baseline. Safety data and responder rates were also assessed., Results: Five hundred thirty-seven patients were randomized, and 82% completed the study. In the intent-to-treat population (n = 533), CRS at doses of > or =300 mg/d (p < or = 0.006) reduced the frequency of partial-onset seizures vs placebo: 6% (placebo) vs 24% (300 mg/d), 21% (800 mg/d), and 29% (1,600 mg/d) for CRS. Adverse events consisted primarily of CNS effects, and led to discontinuation of drug in 8% of the placebo group vs 5% (100 mg/d), 6% (300 mg/d), 12% (800 mg/d), and 19% (1,600 mg/d) of the CRS groups., Conclusions: Carisbamate at doses of 300, 800, and 1,600 mg/d was effective as adjunctive therapy for reducing the frequency of partial-onset seizures.

Objective: To evaluate the effectiveness and safety of a single-dose treatment for acute repetitive seizure (ARS) episodes (e.g., clusters) administered in a nonmedical setting by caregivers., Background: Patients with epilepsy may experience ARS episodes despite optimal anticonvulsant treatment. Such episodes require rapid treatment as medical emergencies. Typically, the patient is treated in an emergency medical setting with i.v. medication by trained medical personnel., Methods: The authors undertook a multicenter, randomized, parallel, double-blind study of a single administration of Diastat (diazepam rectal gel) for treating episodes of ARS. ARS episodes and treatment criteria were defined for each patient at the start of the study. Caregivers were taught to determine ARS episode onset, administer a predetermined dose of study medication, monitor outcome, count respirations, and record seizures and adverse events., Results: A total of 29 centers enrolled 158 patients, of whom 114 patients had a treated ARS episode (Diastat, n = 56; placebo, n = 58). Diastat treatment reduced median seizure frequency (p = 0.029). More Diastat patients were seizure free post-treatment (Diastat, 55%; placebo, 34%; p = 0.031). Kaplan-Meier analysis of the time to the next seizure favored Diastat treatment (p < 0.007). The most common adverse event was somnolence., Conclusion: Administration of a single rectal dose of Diastat was significantly more effective than placebo in reducing the number of seizures following an episode of ARS. Caregivers could administer treatment safely and effectively in a nonmedical setting.

To evaluate perceptions of a pediatrician's attire, 50 children and parents in an outpatient facility were shown five photographs of a female or a male physician dressed differently (formal to informal). A list of positive and negative attributes was presented to the parents and children who were to match each picture to the attributes. Parents had a strong positive preference for the formally dressed female (short white coat and skirt), and the formally dressed male (short white coat and tie). More than 50% of the parents least preferred the most informal attire. Children had no clear preferences for males and preferred the female in the blouse and skirt. Children assigned negative attributes to informal attire but not to the same degree as did their parents. This study demonstrates that parents have stronger preferences than do their children. Although children had no strong positive preferences, they may feel negatively about informal attire.

Umbilical cord serum prolactin concentrations were determined in 17 full-term infants of mothers using narcotic agents during pregnancy and in 18 infants of similar birth weight and gestational age whose mothers did not use narcotics. The median value for the narcotic-exposed group was 266.6 ng/ml (range, 157.5 to 448.7 ng/ml); in the normal group the median was 193.7 ng/ml (range, 69.8 to 693.1 ng/ml). These differences were statistically significant (P less than .05). Although only full-term and borderline premature infants who were not appreciable risk for respiratory distress syndrome (RDS) were studied, it may be speculated that elevated prolactin blood levels in fetuses of addicted mothers may at least in part explain the reported decrease in the incidence of RDS in this group.