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.
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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
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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

Kayla Slupek

(717)304-7442

kslupek@diamedica.com

CONTACT

Adrienne Ford

(717)658-6652

aford@diamedica.com

CONTACT