Lyrica
儿科标签批准日期
2019/5/23 0:00:00
特定指示/秒
Treatment of partial-onset seizures (POS), to include pediatric patients 1 month to less than 4 years
标签更改摘要
- Safety and effectiveness as adjunctive treatment for POS in pediatric patients 1 month to less than 4 years have been established in a 14-day double-blind, placebo-controlled study (N=175). Previously approved in 4 years and older.
- The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses.
- Safety and effectiveness in pediatric patients below the age of 1 month have not been established.
- The most common dose-related adverse reactions (>5%) with Lyrica in this study were somnolence, pneumonia, and viral infection.
- Information on dosing, adverse reactions, PK parameters, and clinical trial.
- Postmarketing study
书号
6.0
5.0
4.0
3.0
2.0
1.0
研究年龄
1 MONTHS - 16 YEARS
5 YEARS - 65 YEARS
1 MONTHS - 16 YEARS
1 MONTHS - 16 YEARS
1 MONTHS - 3 YEARS
4 YEARS - 16 YEARS
学习类型
Efficacy,Safety,Tolerability
Efficacy,Safety,Tolerability
Safety,Tolerability
Safety,Pharmacokinetic,Tolerability
Efficacy,Safety
Efficacy,Safety,Pharmacokinetic
研究设计
Long Term Efficacy,Open Label Extension (with de novo patients)
Multicenter,Randomized,Double-Blind,Parallel Group,Phase 3,Placebo Control
Open Label Extension,Long Term Safety
Phase 1,Placebo Control,Dose Escalation,Multiple Dose
Multicenter,Double-Blind,Parallel Group,Phase 3,Placebo Control
Multicenter,Double-Blind,Parallel Group,Phase 3,Placebo Control
登记的患者
N/A
N/A
N/A
65
175
295
患者分析
N/A
N/A
54
65
175
295
中心的数量
N/A
N/A
13
28
64
78
西班牙裔拉美裔/拉丁裔总计
N/A
N/A
N/A
N/A
N/A
N/A
非西班牙裔/非拉丁裔总人数
N/A
N/A
N/A
N/A
N/A
N/A
亚裔学生总数
N/A
22
3
N/A
52
83
白人总数
N/A
196
40
N/A
120
204
夏威夷或太平洋岛民总数
N/A
0
0
N/A
0
0
美洲印第安人/阿拉斯加本地人总数
N/A
0
0
N/A
0
0
未知种族总数
N/A
N/A
N/A
N/A
N/A
N/A
国家
N/A
N/A
N/A
N/A
N/A
N/A