DM199 for Treating Acute Ischemic Stroke

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

Recruiting Phase 2 Phase 3 Interventional Study
Acute Stroke Ischemic Stroke Stroke
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
728 (estimated)
Sponsor
DiaMedica Therapeutics Inc · Industry
Who this trial is looking for

This trial is looking for adults who have had a moderate stroke and present within 24 hours of the onset. Participants will receive a study medication to see if it helps improve their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 90 years old.
  • I weigh between 40 kg and 166 kg.
  • I had a stroke within the last 24 hours.
  • My stroke severity score is between 5 and 15.
  • I had a good health status before my stroke.
  • I can give my consent or have someone help me do it.
  • I can follow the study instructions.

You may not be able to join if

  • I have bleeding in my brain.
  • I have a large vessel blockage in my brain.
  • I will receive mechanical thrombectomy for my stroke.
  • I have serious allergic reactions or a history of them.
  • I am pregnant or nursing.
  • I have an active infection requiring hospitalization.
  • I have been diagnosed with hereditary angioedema.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This 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 limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eli…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participant is between 18 and 90 years of age inclusive. 2. Participant weight is 40 kg to 166 kg inclusive. 3. Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset. 4. Participant has NIHSS ≥5 and ≤15 at approximately the…
Contacts

Shanique Smythe - Peterkin

763-265-4560

SSmythe-Peterkin@diamedica.com

CONTACT