Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429384
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-04-03
Brief Title:
Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial -- Multicenter Randomized Double-blind Parallel Placebo-controlled Phase II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The objective of this clinical trial was to explore the efficacy and safety of Y-3 injection at different doses in patients with acute ischemic stroke within 48 hours of onset
A multicenter randomized double-blind parallel placebo-controlled trial design was designed to include 240 participants
Subjects press 111 1 ratio of patients were randomly divided into Y-3 low-dose group 20 mg time qd medium-dose group 40 mg time qd high-dose group 60mg time qd and placebo control group with 60 cases in each group Random stratification factors include
Time of onset 24 hours gt 24 hours The patients were treated for 10 consecutive days 10 times and followed up to 90 days after the first dose
The trial was divided into three phases screeningbaseline treatment and follow-up
Screeningbaseline period Subjects enter the screeningbaseline period for screening examination after signing the informed consent
Treatment period Eligible subjects were randomly assigned at a ratio of 1111 to receive Y-3 injection low-dose group medium-dose group high-dose group and placebo control drug for 10 consecutive days 10 times during which relevant examinations required by the protocol were conducted and safety was assessed
Follow-up period Participants who finished treatment were followed up until 90 days after the first dose
Stroke-related scale scores were performed at 10 30 and 90 days after first use of the investigational drug The scores of Montgomery Depression Rating Scale MSAS and Hamilton Anxiety Scale HAMA were performed on the 10th and 90th days after the use of experimental drugs Adverse events were recorded during treatment and follow-up to further assess safety
A multicenter randomized double-blind parallel placebo-controlled trial design was designed to include 240 participants
Subjects press 111 1 ratio of patients were randomly divided into Y-3 low-dose group 20 mg time qd medium-dose group 40 mg time qd high-dose group 60mg time qd and placebo control group with 60 cases in each group Random stratification factors include
Time of onset 24 hours gt 24 hours The patients were treated for 10 consecutive days 10 times and followed up to 90 days after the first dose
The trial was divided into three phases screeningbaseline treatment and follow-up
Screeningbaseline period Subjects enter the screeningbaseline period for screening examination after signing the informed consent
Treatment period Eligible subjects were randomly assigned at a ratio of 1111 to receive Y-3 injection low-dose group medium-dose group high-dose group and placebo control drug for 10 consecutive days 10 times during which relevant examinations required by the protocol were conducted and safety was assessed
Follow-up period Participants who finished treatment were followed up until 90 days after the first dose
Stroke-related scale scores were performed at 10 30 and 90 days after first use of the investigational drug The scores of Montgomery Depression Rating Scale MSAS and Hamilton Anxiety Scale HAMA were performed on the 10th and 90th days after the use of experimental drugs Adverse events were recorded during treatment and follow-up to further assess safety
Detailed Description:
A multicenter randomized double-blind parallel placebo-controlled trial design was designed to include 240 participants who were randomly assigned to Y-3 low-dose group 20 mg time qd medium-dose group 40 mg time qd high-dose group 60 mg time qd and placebo control group in a ratio of 1111 Each group had 60 cases
Random stratification factors included onset time 24 hours 24 hoursThe patients were treated for 10 consecutive days 10 times and followed up to 90 days after the first dose
The trial was divided into three phasesscreeningbaseline treatment and follow-up
Screeningbaseline period Subjects enter the screeningbaseline period for screening examination after signing the informed consentTreatment period Eligible subjects were randomly assigned at a ratio of 1111 to receive Y-3 injection low-dose group medium-dose group high-dose group and placebo control drug for 10 consecutive days 10 times during which relevant examinations required by the protocol were conducted and safety was assessedFollow-up period Participants who finished treatment were followed up until 90 days after the first doseStroke-related scale scores were performed on the 10th 30th and 90th days after the first use of the experimental drug and Montgomery Depression Rating Scale MADRS and Hamilton Anxiety Scale HAMA scores were performed on the 10th and 90th days after the first use of the experimental drug Adverse events were recorded during treatment and follow-up to further assess safety
Random stratification factors included onset time 24 hours 24 hoursThe patients were treated for 10 consecutive days 10 times and followed up to 90 days after the first dose
The trial was divided into three phasesscreeningbaseline treatment and follow-up
Screeningbaseline period Subjects enter the screeningbaseline period for screening examination after signing the informed consentTreatment period Eligible subjects were randomly assigned at a ratio of 1111 to receive Y-3 injection low-dose group medium-dose group high-dose group and placebo control drug for 10 consecutive days 10 times during which relevant examinations required by the protocol were conducted and safety was assessedFollow-up period Participants who finished treatment were followed up until 90 days after the first doseStroke-related scale scores were performed on the 10th 30th and 90th days after the first use of the experimental drug and Montgomery Depression Rating Scale MADRS and Hamilton Anxiety Scale HAMA scores were performed on the 10th and 90th days after the first use of the experimental drug Adverse events were recorded during treatment and follow-up to further assess 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