通用名称

deutetrabenazine

儿科标签批准日期

2021/6/24 0:00:00

特定指示/秒

Tourette Syndrome

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients for the treatment of Tourette syndrome. - Efficacy was not demonstrated in two randomized, double-blind, placebo-controlled studies in pediatric patients aged 6 to 16 years with Tourette syndrome. - One study evaluated fixed doses of deutetrabenazine over 8 weeks; the other evaluated flexible doses of deutetrabenazine over 12 weeks. The studies included a total of 274 pediatric patients who received at least one dose of deutetrabenazine or placebo. - Information on adverse reactions, and clinical trials.

治疗类别

Other Movement Disorders

立法类型

BPCA Only

产品说明书链接

书号

4.0 3.0 2.0 1.0

研究年龄

12 YEARS - 19 YEARS 6 YEARS - 17 YEARS 6 YEARS - 16 YEARS 6 YEARS - 16 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Tolerability Safety,Tolerability Efficacy,Safety,Tolerability Efficacy,Safety,Tolerability

研究设计

Open-Label,Phase 1 Open-Label,Phase 3,Long-term,Single-arm Randomized,Placebo,Double-Blind,Parallel Group,Phase 3 Multicenter,Randomized,Placebo,Double-Blind,Parallel Group,Phase 2,Phase 3

登记的患者

23 228 158 119

患者分析

23 228 158 119

中心的数量

9 77 52 36

国家数量

1 15 10 6

西班牙裔拉美裔/拉丁裔总计

1 38 32 13

非西班牙裔/非拉丁裔总人数

22 186 125 101

总数#种族不明

0 4 1 5

亚裔学生总数

0 7 7 2

黑人总数

0 4 1 6

白人总数

22 197 135 102

夏威夷或太平洋岛民总数

0 0 0 0

美洲印第安人/阿拉斯加本地人总数

0 5 4 1

其他种族总计

1 15 11 8

未知种族总数

0 0 0 0

国家

United States United States,Argentina,Australia,Canada,Colombia,Denmark,Hungary,Italy,Korea, Republic of,Mexico,Poland,Russian Federation,Serbia,Spain,Ukraine United States,Argentina,Australia,Colombia,Hungary,Italy,Korea, Republic of,Mexico,Poland,Ukraine United States,Canada,Denmark,Russian Federation,Serbia,Spain