Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
NCT05065216 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 728 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DiaMedica Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05065216 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05065216?
This trial is sponsored by DiaMedica Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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