Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05065216
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-09-03
Brief Title:
Treatment of Acute Ischemic Stroke ReMEDy2 Trial
Sponsor:
DiaMedica Therapeutics Inc
Organization:
DiaMedica Therapeutics Inc
Study Overview
Official Title:
Phase 23 Adaptive Design Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke ReMEDy2 Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ReMEDy2
Brief Summary:
This is a Phase 23 study evaluating the safety and efficacy of DM199 in treating participants presenting within 24 hours of Acute Ischemic Stroke AIS onset for whom fibrinolytics andor a catheter-based procedure mechanical thrombectomy MT are not medically appropriate or available due to constraints of clot location comorbidity risks andor time from estimated onset of stroke The double-blinded study will be randomized placebo controlled at up to approximately 100 sites
Detailed Description:
This is a randomized double-blind placebo-controlled Phase 23 adaptive multi-center study to evaluate the safety and efficacy of DM199 for the treatment of acute ischemic stroke Participants with AIS will be randomized 11 to DM199 or placebo placebo is normal saline given with the same route IV or SC volume and frequency as DM199 administered as a single intravenous IV dose followed by a subcutaneous SC dose within 2-12 hours of IV dose completion and then 2 times per week for three weeks until Day 21 After dosing is complete participants will be followed up by the investigator at approximately 30 and 90 days after their first dose
A formal interim analysis will be conducted after 144 participants complete their Day 90 assessment in Part A The purposes of this interim analysis are to assess safety allow early stopping of the study for futility or continuing the study with a revised final sample size of between 240 up to 728 The futility rule will be non-binding
A formal interim analysis will be conducted after 144 participants complete their Day 90 assessment in Part A The purposes of this interim analysis are to assess safety allow early stopping of the study for futility or continuing the study with a revised final sample size of between 240 up to 728 The futility rule will be non-binding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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