| 项目编号 |
PRJCA012649 |
| 项目标题 |
A randomized, double blind, placebo, multicenter, parallel group study to evaluate the efficacy and safety of adjunctive brivaracetam in subjects with partial seizures |
| 涉及领域 |
Medical |
| 数据类型 |
ICON Central Test Data
|
| 物种名称 |
Homo sapiens
|
| 描述信息 |
This is a randomized, double-blind, placebo controlled, multicenter, parallel-group study designed to evaluate the efficacy and safety of adjunctive brivaracetam in subjects with partial seizures. The primary objective is to evaluate the efficacy of BRV compared to PBO as adjunctive treatment in adult and adolescent focal epilepsy subjects with partial seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs. Secondary objectives are to assess the safety and tolerability of BRV and to characterize the steady-state pharmacokinetics of BRV in subjects from 16 to 80 years of age. |
| 样品范围 |
ICON Central Test Data |
| 发布日期 |
2022-10-22 |
| 项目资金来源 |
| 机构 |
项目类型 |
授权项目ID |
授权项目名称 |
| UCB Biopharma SRL
|
|
N/A
|
|
|
|
| 提交者 |
Xintong
Wu (36853839@qq.com)
|
| 提交单位 |
West China Hospital of Sichuan University |
| 提交日期 |
2022-10-20 |
