Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315231
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-11
Brief Title:
Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients
Sponsor:
Simcere Pharmaceutical Co Ltd
Organization:
Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke a Multicenter Randomized Double-blind Placebo-controlled Exploratory Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a multicenter randomized double-blind placebo-controlled exploratory Phase II clinical trial
The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke
Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo
The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke
Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo
Detailed Description:
None
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