Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299579
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-27
Brief Title:
GD-11 for Injection in the Treatment of Acute Ischemic Stroke
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke
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:
Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center Randomized Double-Blind Parallel Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours The subject has a clinical diagnosis of acute ischemic stroke 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 mRS score 1 at 90 days after treatment
Detailed Description:
A multicenter randomized double-blind parallel placebo-controlled trial design was used Subjects were randomly assigned in a 11 ratio to the experimental group GD-11 for injection treatment group and the control group GD-11 for injection placebo group Randomization stratification factors included onset time 24 hours 24 hours and centerContinuous treatment was performed for 10 days 20 times followed up to 90 days after the first administration
The trial was divided into three phases screeningbaseline phase treatment phase and follow-up phase
Screeningbaseline phase Subjects entered the screeningbaseline phase after signing the informed consent for screening examinations
Treatment phase Eligible subjects were randomly assigned in a 11 ratio to receive GD-11 for injection or placebo for injection for 10 days 20 times During the treatment protocol-required examinations were performed and safety was evaluated
Follow-up phase Subjects who completed the treatment entered the follow-up phase and were followed up to 90 days after the first administration
Stroke-related scale scores were performed on the 10th 30th and 90th days after the first use of the test drug Adverse events were recorded during the treatment and follow-up phases to further evaluate safety
The trial was divided into three phases screeningbaseline phase treatment phase and follow-up phase
Screeningbaseline phase Subjects entered the screeningbaseline phase after signing the informed consent for screening examinations
Treatment phase Eligible subjects were randomly assigned in a 11 ratio to receive GD-11 for injection or placebo for injection for 10 days 20 times During the treatment protocol-required examinations were performed and safety was evaluated
Follow-up phase Subjects who completed the treatment entered the follow-up phase and were followed up to 90 days after the first administration
Stroke-related scale scores were performed on the 10th 30th and 90th days after the first use of the test drug Adverse events were recorded during the treatment and follow-up phases to further evaluate safety
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