| Accession |
PRJCA012649 |
| Title |
A randomized, double blind, placebo, multicenter, parallel group study to evaluate the efficacy and safety of adjunctive brivaracetam in subjects with partial seizures |
| Relevance |
Medical |
| Data types |
ICON Central Test Data
|
| Organisms |
Homo sapiens
|
| Description |
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. |
| Sample scope |
ICON Central Test Data |
| Release date |
2022-10-22 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| UCB Biopharma SRL
|
|
N/A
|
|
|
|
| Submitter |
Xintong
Wu (36853839@qq.com)
|
| Organization |
West China Hospital of Sichuan University |
| Submission date |
2022-10-20 |
