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NCT05065216 · ClinicalTrials.gov registry record · Phase 2
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
A Phase 2 study of Stroke and Ischemic Stroke, sponsored by DiaMedica Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 728
- Enrollment target
- 20
- Study locations
NCT05065216 is a Phase 2 study of Stroke and Ischemic Stroke that is actively recruiting participants, run by DiaMedica Therapeutics. The registered enrollment target is 728 participants, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT05065216, a Phase 2 study of Stroke and Ischemic Stroke, is actively recruiting participants, sponsored by DiaMedica Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 728 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Recombinant human tissue kallikrein
- OTHER Placebo for DM199 Solution for Injection
Study Locations (20)
California
- USC Arcadia Hospital - Arcadia
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale - Glendale
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Ronald Reagan UCLA Medical Center - Los Angeles
- Stanford Health Care - Stanford
- The Lundquist Institute at Harbor UCLA Medical Center - Torrance
- Memorialcare Long Beach Medical Center - Torrance
Florida
- HCA Florida - JFK Medical Center - Atlantis
- Holy Cross Health - Fort Lauderdale
- University of Florida Jacksonville - Jacksonville
- Sarasota Memorial Hospital - Sarasota
- Tampa General Hospital (TGH) - The Stroke Center - Tampa
Alabama
- Gulf Health Hospitals d/b/a Thomas Hospital - Fairhope
Illinois
- OSF HealthCare Saint Francis Medical Center - Peoria
Indiana
- Community Hospital - MacArthur - Munster
Kansas
- Ascension Via Christi Hospitals Wichita Inc. - Wichita
Louisiana
- Ochsner Clinic Foundation - New Orleans
Massachusetts
- UMASS Chan Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 728 participants |
| Start Date | 2021-11-07 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05065216
The ClinicalTrials.gov registry entry for NCT05065216 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 728 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (94% lower). The listed sponsor is DiaMedica Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Recombinant human tissue kallikrein is the first listed.
NCT05065216 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05065216 about?
NCT05065216 is a clinical study titled "Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)". 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 limit...
What is the current status of trial NCT05065216?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 728 participants. The study started on 2021-11-07. Estimated completion is 2026-12.
What conditions does trial NCT05065216 study?
This clinical trial studies the following conditions: Stroke, Ischemic Stroke, Acute Stroke.
What interventions are being tested in trial NCT05065216?
The interventions under investigation include: Recombinant human tissue kallikrein (DRUG), Placebo for DM199 Solution for Injection (OTHER).
Who is sponsoring clinical trial NCT05065216?
This trial is sponsored by DiaMedica Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05065216 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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