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Clinical Trial Summary

This is a Phase 2/3 study to evaluate the safety, tolerability, and efficacy of DM199 in treating acute ischemic stroke patients presenting with AIS and for whom tPA and a catheter-based procedure, MT, are not medically appropriate or available due to constraints of clot location, comorbidity risks, and/or time from onset of stroke (LVO is excluded from this study). The double-blinded study will be randomized, placebo controlled at up to 75 centers.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled Phase 2/3 seamless adaptive, multi-center study to evaluate the efficacy, safety and tolerability of DM199. Patients presenting with acute ischemic stroke will be randomized in 1:1 to placebo or DM199 administered by a single intravenous (IV) dose followed by a subcutaneous (SC) dose within 12 hours and then 2 times a week till Day 22. The duration of each individual's participation in the study will be 90 days from the time of consent to completion of all study activities. Figure 1 depicts the overall study design. An interim analysis will be conducted at the end of Phase 2 of the study after approximately 144 patients complete their Day 90 assessments. Additional patients will continue to be enrolled while the database and interim statistical analysis are prepared for review. A Data Safety Monitoring Board (DSMB) will review the interim data for efficacy and safety to determine if the trial will proceed into Phase 3. The adaptive feature of the study includes a formal interim assessment of efficacy and the possibility for increasing the sample size. The study is initially planned to enroll an additional 220 patients in Phase 3 (N=364 total). If sample size re-estimation is deemed appropriate from the interim analysis, a maximum of 584 patients may be enrolled in Phase 3 (N=728 total). This adaptive design is (inferentially) seamless because it continues from Phase 2 to Phase 3 without pausing enrollment and because all (N=364 to 728 total) patients in the study will be included in the final statistical analysis. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05065216
Study type Interventional
Source DiaMedica Therapeutics Inc
Contact Harry Alcorn, PharmD
Phone 763-312-6064
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date September 24, 2021
Completion date September 2024

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