Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06176781
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
The Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With AIS
Sponsor:
Simcere Pharmaceutical Co Ltd
Organization:
Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With Acute Ischemic Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
SIM0308-302 is a multicenter randomized double-blind placebo-controlled clinical III trial with the primary objective of evaluating the efficacy of Edaravone Dexborneol sequential therapy consisting of Edaravone Dexborneol Injections followed by Edaravone Dexborneol Sublingual Tablets for total 14 days in patients with acute ischemic stroke AIS The subject has a clinical diagnosis of AIS within 48 hours from stroke onset to start of study treatment with a National Institutes of Health Stroke Scale NIHSS between 6 and 20 had a total score of upper and lower limbs on motor deficits 2 The primary outcome is the proportion of subjects with modified Rankin scale score 2 at 90 days after treatment
Detailed Description:
SIM0308-302 is a multicenter randomized double-blind placebo-controlled clinical III trial with the primary objective of evaluating the efficacy of Edaravone Dexborneol sequential therapy consisting of Edaravone Dexborneol Injections followed by Edaravone Dexborneol Sublingual Tablets for total 14 days in patients with acute ischemic stroke AIS The subject has a clinical diagnosis of AIS within 48 hours from stroke onset to start of study treatment with a NIHSS score between 6 and 20 had a total score of upper and lower limbs on motor deficits 2 The primary outcome is the proportion of subjects with modified Rankin scale score 1 at 90 days after treatment The secondary outcomes included mRS score on day 90 the proportion of subjects with mRS score 2 on day 90 the change of NIHSS score from baseline to day 14 and the proportion of subjects with NIHSS score 1 on day 14 30 90 after treatment Safety outcomes included adverse events treatment related adverse events within day 90 and changes in vital signs and laboratory data before and after treatment
Subjects in the Sequential group receive Edaravone Dexborneol concentrated solution for injections 375 mg BID administered intravenously for 5 - 10 days and then followed by Edaravone Dexborneol Sublingual Tablets 30 mg BID administered sublingually for the last days the total duration of treatment was 14 days Subjects in the Placebo group receive placebo for 14 days All the subjects were followed up to day 90 after the treatment
Subjects in the Sequential group receive Edaravone Dexborneol concentrated solution for injections 375 mg BID administered intravenously for 5 - 10 days and then followed by Edaravone Dexborneol Sublingual Tablets 30 mg BID administered sublingually for the last days the total duration of treatment was 14 days Subjects in the Placebo group receive placebo for 14 days All the subjects were followed up to day 90 after the treatment
Study Oversight
Has Oversight DMC:
None
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?:
None