Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612775
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Study to Evaluate the Safety Tolerability and Efficacy of CB03-154 in Adult Patients With Focal Epilepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate the Safety Tolerability and Efficacy of CB03-154 as Adjunctive Therapy in Focal Epilepsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc for the treatment of Focal Epilepsy
Detailed Description:
The purpose of this study is to evaluate the effectiveness of CB03-154 on focal seizure frequency by comparing with placebo see how safe the study drug is and assess how well it is tolerated after dosing in adults with focal epilepsy taking 1 to 3 AEDs in the double-blind trial The study will also test the 50 response rates of the study drug and see how it is taken up and eliminated by the body An additional part of the study is to look how will the study drug influence the trends of frequency and seizure severity in the double-blind trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None