Ask your competent? doctor to explain the previous FDA hold on this research and notify you of the results when research is completed. No knowledge of this at all is fucking complete incompetence! I expect my doctors and therapists to be completely up to date on all research in the stroke field. You should be getting this information from your doctor, not me.
DM199
(2 posts to August 2022)
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
ClinicalTrials.gov ID NCT05065216
Information Provided by Scott Kasner, MD Study Start (Actual) 2021-11-07 Primary Completion (Estimated) 2026-12 Study Completion (Estimated) 2026-12 Enrollment (Estimated) 728 Study Type Interventional Last Update Posted 2025-09-25 Study Overview Brief Summary This is a Phase 2/3 study evaluating the safety and efficacy of ClinicalTrials.gov ID NCT05065216 Sponsor DiaMedica Therapeutics Inc Information Provided byScott Kasner, MD< Study Start (Actual)2021-11-07 Primary Completion (Estimated) 2026-12 Study Completion (Estimated) 2026-12 Enrollment (Estimated) 728 Study Type Interventional Last Update Posted 2025-09-25 Study Overview>This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.To learn more, visit ClinicalTrials.gov (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.ClinicalTrials.gov
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