通用名称

sodium oxybate

儿科标签批准日期

2018/10/26 0:00:00

特定指示/秒

Treatment of cataplexy or excessive daytime sleepiness to pediatric patients 7 years of age and older with narcolepsy

标签更改摘要

- Safety and effectiveness in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years and older with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study - Safety and effectiveness in pediatric patients below the age of 7 years have not been established. - The adverse reaction profile in the pediatric clinical trial was similar to that seen in the adult clinical trial program. - In the pediatric clinical trial with Xyrem administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation; suicidal ideation in one patient; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported. - Information on dosing, adverse reactions, clinical trial and PK parameters. - Postmarketing study.

治疗类别

N/A

立法类型

BPCA Only

产品说明书链接

书号

1.0

研究年龄

7 YEARS - 16 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic

研究设计

Double-Blind,Randomized-Withdrawal,with Open Label PK Extension,Placebo Control

登记的患者

106

患者分析

96

中心的数量

30

国家数量

5

西班牙裔拉美裔/拉丁裔总计

6

非西班牙裔/非拉丁裔总人数

100

总数#种族不明

0

亚裔学生总数

3

黑人总数

25

白人总数

73

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

0

其他种族总计

5

未知种族总数

N/A

国家

N/A