[<\/b>编者按<\/b>]<\/b><\/p> \n
About Study 311<\/b><\/p> \n
Study 311 is a global (United States<\/span>, Europe<\/span>, Japan<\/span>, Asia<\/span>) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of Fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.<\/p> \n Following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of Fycompa orally once-daily, long term safety was assessed during an extension phase. In Japan<\/span>, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of Fycompa orally once-daily. The adverse events (≥10% in the perampanel arms) observed in Study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.<\/p> \n About Study 232<\/b><\/p> \n Study 232 was a global (United States<\/span>, Europe<\/span>), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). The study evaluated the pharmacokinetics, safety, tolerability and efficacy of Fycompa oral suspension taken at the same time as other AEDs. Administration of once-daily Fycompa was titrated from 0.015 mg\/kg to 0.18 mg\/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). The most common adverse events (≥10% in the perampanel arms) observed in Study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.<\/p>"];
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