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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
At a glance
Conditions
Where it's being run
86 sites across 35 statesStudy leadership
- Jay Volpi, M.D. · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
- Rachel Laursen, M.D. · PRINCIPAL_INVESTIGATOR · Oregon Health & Science University (OHSU)
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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).