Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-30 @ 10:58 PM
Study NCT ID:
NCT05953103
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2023-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage
Sponsor:
Simcere Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
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:
The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate for injection combined with conventional medical therapy in patients with cerebral hemorrhage. The subject had a clinical diagnosis of cerebral hemorrhage, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Synbixin 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Synbixin 62.5 mg; placebo group).
Detailed Description:
The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate for injection combined with conventional medical therapy in patients with cerebral hemorrhage. The subject had a clinical diagnosis of cerebral hemorrhage, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Synbixin 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Synbixin 62.5 mg; placebo group). Safety was assessed unblinding after the end of study treatment for all subjects in the first dose level group and escalated to the second dose level if the "safe dose" criterion was met, otherwise the trial was terminated; safety was assessed unblinding after the end of study treatment for all subjects in the second dose level group and the 62.5 mg dose level was selected to enter Stage B if the "safe dose" criterion was met, otherwise the 37.5 mg dose level was selected to enter Stage B.
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?: