Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 11:44 PM
Study NCT ID:
NCT07238868
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study to Evaluate Safety, Tolerability, and Efficacy of CB03-154 in Subjects Diagnosed With Epilepsy
Sponsor:
Shanghai Zhimeng Biopharma, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed With Epilepsy
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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:
This is an open-label extension study based on the Phase 2 clinical trial CB03-154-EP201. The study aims to assess the long-term safety, tolerability, efficacy, and pharmacokinetics (PK) of CB03-154 at a maximum dose of 20 mg administered orally once daily (QD) in patients with epilepsy. Eligible subjects are those who successfully completed the prior CB03-154-EP201 study without early discontinuation. The treatment in this extension study will last for up to two years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: