Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645522
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke
Detailed Description:
In this study 1200 patients with acute ischemic stroke within 48 hours from the onset are included in several centres in China according to the principles of randomization double-blind and parallel control The experimental group receives basic treatment and edaravone dexborneol injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol for 21 consecutive days The placebo group receives basic treatment and edaravone dexborneol placebo injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol placebo drug for 21 consecutive days Two groups will be followed up at day 90 to evaluate the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke
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