ReMEDy2 Trial: DM199 for Acute Ischemic Stroke

This study is testing a drug called DM199 (rinvecalinase alfa) to see if it can help people recover from a moderate acute ischemic stroke (a stroke caused by a blood clot). You might be able to join if you are between 18 and 90 years old, weigh between 40 and 166 kg, and had your stroke within the last 24 hours. Your stroke severity, measured by a scale called NIHSS, should be between 5 and 15. The study will compare DM199 to a placebo (an inactive substance) to see which is more effective in helping with stroke recovery after 90 days. The study plans to enroll up to 728 participants, but its current recruitment status is unclear.

Study design
This is a Phase 2/3 adaptive design study where participants are randomly assigned to receive either DM199 or a placebo. It is double-blind, meaning neither you nor your doctors will know which treatment you are receiving.
What's involved
You would receive DM199 or placebo through a single intravenous (IV) dose, followed by subcutaneous (SC) doses for up to 21 days. Your participation in the study will last about 90 days.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for approximately 90 days after your initial treatment to assess stroke recovery.

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NCT05065216

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

Recruiting
PHASE2Ages 18–90InterventionalTreatment
DiaMedica Therapeutics Inc
~728 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Recombinant human tissue kallikreinPlacebo for DM199 Solution for Injection

At a glance

Recruiting sites
76 of 86 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stroke Recovery
Measured over Day 90
Acute Stroke
Ischemic Stroke
Stroke
86 sites across 35 states
United Kingdom10
California7
Florida6
Georgia6
Belgium6
Poland6
France4
Hungary4
  • Jay Volpi, M.D. · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
  • Rachel Laursen, M.D. · PRINCIPAL_INVESTIGATOR · Oregon Health & Science University (OHSU)

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and
Participant's initial NIHSS score prior to fibrinolytics was ≤15; and
At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and
The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and

Exclusion

Combined (estrogen and progesterone containing) hormonal oral, intravaginal, or transdermal contraception associated with the inhibition of ovulation
Progesterone-only oral, injectable, or implantable hormonal contraception associated with the inhibition of ovulation
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner
Sexual abstinence Participants who are not of reproductive potential (who have been postmenopausal for more than 24 consecutive months or have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) are not required to use contraception.
  • Stroke RecoveryDay 90

    Stroke recovery as defined by participants with excellent functional outcomes at Day 90 as assessed via the Modified Rankin Score (mRS \[dichotomized\]), mRS scores of 0 or 1 represent responders, scale range of 0-6. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).