Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374667
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-16
Brief Title:
The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction
Sponsor:
yilong Wang
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric InfarctionSOLUTION-2
Status:
RECRUITING
Status Verified Date:
2024-04
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:
SOLUTION-2
Brief Summary:
A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseousICO injection in patients with malignant middle cerebral artery infarction mMCAI showing a trend in improving 90-day functional scores compared to conventional treatment The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarctionLHI who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes
Detailed Description:
The mortality rate of large hemispheric infarctionLHI is up to 40-60 while current available treatment is limited Mainstream therapeutics include endovascular reperfusion therapy and decompressive craniectomy But endovascular-reperfusion has limits such as short time window and hemorrhagic transformation risk while decompressive craniectomy can reduce mortality but not infarct volume Curative effect of intravenous injection of neuroprotective drugs is severely limited because of the blood-brain barrier Microchannels connecting the skull bone marrow and dura may be effective drug delivery shortcuts bypassing the blood-brain barrier Cytoprotective drug Y-3 affects dual aspects of ischemic cascade by disrupting both function of the synaptic folding post-synaptic density protein 95 PSD-95 as well as α2-γAminobutyric acid type A receptor α2-GABAAR agonist Phase I and Phase II clinical trials have confirmed the safety and efficacy of intravenous infusion of Y-3 in treating cerebral infarction with the optimal dosage being 40mg Preclinical testing proved that ICO injection of Y-3 solution 24h post rat permanent middle cerebral artery infarction reduced rat infarction volume and improved neurological function
SOLUTION-2 is a multicentered prospective randomized open-label blinded end-point PROBE study
The purpose of this study is to investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in acute LHI patients with contraindications of reperfusion therapy or poor outcomes
Patients will be randomly assigned to one of the following 2 groups at 11 ratio
ICO injection group Y-3 ICO injection dose was given as 32 ugkg once a day for 3 consecutive days as well as standard treatment and management according to the related guidelines
intravenous injection group Y-3 intravenous injectiondose was given as 40mg 250ml normal saline as well as standard treatment and management according to related guidelines
Face to face interviews will be made on baseline 41 days after randomization 81 days after randomization 141 days after randomization or discharge day and 90 days after randomization
The primary efficacy outcomes is the modified Rankin ScalemRS 0-3 points at 907 days A Data and Safety Monitoring Board DSMB will regularly monitor safety during the study The trial has been approved by Institutional Review Board IRB and Ethics Committee EC in Being Tiantan hospital Capital Medical University
SOLUTION-2 is a multicentered prospective randomized open-label blinded end-point PROBE study
The purpose of this study is to investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in acute LHI patients with contraindications of reperfusion therapy or poor outcomes
Patients will be randomly assigned to one of the following 2 groups at 11 ratio
ICO injection group Y-3 ICO injection dose was given as 32 ugkg once a day for 3 consecutive days as well as standard treatment and management according to the related guidelines
intravenous injection group Y-3 intravenous injectiondose was given as 40mg 250ml normal saline as well as standard treatment and management according to related guidelines
Face to face interviews will be made on baseline 41 days after randomization 81 days after randomization 141 days after randomization or discharge day and 90 days after randomization
The primary efficacy outcomes is the modified Rankin ScalemRS 0-3 points at 907 days A Data and Safety Monitoring Board DSMB will regularly monitor safety during the study The trial has been approved by Institutional Review Board IRB and Ethics Committee EC in Being Tiantan hospital Capital Medical University
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