New stroke drug aims to help patients missed by standard treatments

NCT ID NCT05065216

Disease control Sponsor: DiaMedica Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a drug called DM199 in about 728 people who have had a moderate stroke and cannot get clot-removing treatments. The drug is given through a vein and then as shots under the skin for three weeks. Researchers want to see if it helps patients recover better than a placebo, measured by their ability to do daily activities 90 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: DM199 (rinvecalinase alfa), a lab-made version of a human protein that may help repair blood flow after stroke
What this could lead to: If it works, this could offer a new treatment option for people with moderate stroke who cannot get standard therapies like clot removal.
What could go wrong: This is an early-to-mid-stage trial, so success is not guaranteed. The drug may not improve recovery or could cause side effects like bleeding.

Why investors are watching

DiaMedica Therapeutics is running a Phase 2/3 trial of DM199, a drug for acute ischemic stroke in patients who cannot get standard clot-removal procedures. The trial enrolls 728 patients and tests whether the drug improves outcomes in a group with limited options. For a micro-cap company with few products, this readout is the main driver of its value.

If it works: A positive result could establish DM199 as a new treatment option for stroke patients who are ineligible for mechanical thrombectomy. That success could lead to regulatory approval and a commercial product, which would transform a company of this size.

If it fails: Trials in stroke often fail, and a negative or unclear result could leave DiaMedica without a viable lead drug. A delay in enrollment or data could also strain the company's limited resources.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 728 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 time of randomization. This criterion also applies to participants who meet the following conditions: * 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 meets all other inclusion and exclusion criteria, including repeat brain imaging to rule out hemorrhagic transformation. 5. Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative. 6. If participant has received fibrinolytic treatment for AIS within 4.5 hours of last know normal/AIS stoke onset and at least 6 hours after completing fibrinolytic treatment, and the participant meets all of the following criteria: * 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 * Participant meets all other inclusion and exclusion criteria including repeat brain imaging to rule out hemorrhagic transformation. 7. Participant and/or legally authorized representative is able to provide informed consent. 8. Participant is willing and able to comply with the study protocol, in the Investigator's judgment. Exclusion Criteria: 1. At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke. 2. Participant has image findings with symptomatic large vessel occlusion at one or more of the following locations: Intracranial carotid I/T/L or M1 segment MCA, vertebral or basilar artery (BA). 3. Participant has large core of established infarction defined as ASPECTS 0-5. 4. Participant has or will receive MT for their current AIS. 5. Participant has suspected or confirmed extracranial arterial dissection. 6. Participant has imaging findings and/or symptoms consistent with a brain stem or cerebellar stroke. Posterior cerebral artery strokes without any associated brain stem or cerebellar involvement are allowable. 7. Participant has any recorded SBP \<100 mmHg or MAP \<65 mmHg; MAP = DBP + \[1/3 (SBP - DBP)\] (measured with noninvasive BP cuff type monitor) after stroke symptom onset and prior to randomization. 8. Participant is currently prescribed angiotensin-converting enzyme inhibitor (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment through Day 29 ±1 day (8 days after last treatment). 9. Participant is currently prescribed an ACEi, and the last dose of the ACE inhibitor medication is reported to have been taken \< 24 hours before start of IV study drug infusion as stated by participant or participant's representative. 10. Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization. 11. Participant has a diagnosis or suspected diagnosis of hereditary angioedema (HAE) or is taking or prescribed medications commonly used as prophylaxis/treatment of HAE, such as C1-esterase inhibitors (Cinryze, Berinert, Ruconest, Haegarda), Danazol, kallikrein inhibitors (Ecallantide, Berotralstat, Lanadelumab), Bradykinin B2 Receptor Antagonists (Icatibant), or other medication designed to influence the kallikrein-kinin system. 12. Life expectancy estimated at ≤1 year prior to enrollment. 13. Participant has clinical evidence of an active infection at the time of enrollment requiring parenteral treatment or hospitalization to monitor or manage the infection. NOTE: Treatment of uncomplicated infections with oral antibiotics would not be an exclusion (for example, the treatment of uncomplicated urinary tract infections or sinus infections with oral antibiotics would not be exclusionary). 14. Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency). 15. Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator. 16. Participants of child-bearing potential must agree to use medically acceptable contraceptive measures to prevent pregnancy. All participants of childbearing potential (defined as sexually mature participants who have had menses within the preceding 24 months and have not undergone permanent sterilization methods such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) must have a negative serum pregnancy test performed locally at screening. Participants of childbearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization. If participating in sexual activity that could lead to pregnancy, participants must use 2 reliable methods (1 per partner is acceptable) of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period. Participants participating in sexual activity must agree to use, or for their partner to use highly effective birth control methods (those with a failure rate of less than 1% per year when used consistently and correctly) until they have completed the study (after the Day 90 visit). Such methods include: * 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. Participants are prohibited from sperm donation. NOTE: A negative serum pregnancy test will be documented during screening if a participant is of child-bearing potential. 17. Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening. 18. Participant does not have sufficient venous access for infusion of study treatment or blood sampling. 19. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits. 20. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.

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Conditions

The condition(s) this trial relates to.

ischemic disease ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute stroke Ischemic stroke Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

81 sites in 9 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu
NOT_YET_RECRUITING

Wroclaw, Poland
AZ Groeninge
RECRUITING

Kortrijk, 8500, Belgium
Abbott Northwestern Hospital
RECRUITING

Minneapolis, Minnesota, 55407, United States
Addenbrooke's Hospital
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Aphm Hopital Timone
RECRUITING

Marseille, France
Ascension St. John
RECRUITING

Tulsa, Oklahoma, 74104, United States
Ascension Via Christi Hospitals Wichita Inc.
RECRUITING

Wichita, Kansas, 67214, United States
B.-A.-Z. County Central Hospital
RECRUITING

Miskolc, 3526, Hungary
Bajcsy-Zsilinszky Hospital
RECRUITING

Budapest, 1106, Hungary
Barts Health NHS Trust The Royal London Hospital
NOT_YET_RECRUITING

London, United Kingdom
Boca Raton Regional Hospital Marcus Neuroscience Institute
RECRUITING

Boca Raton, Florida, 33486, United States
CHC Montléga
RECRUITING

Liège, 4000, Belgium
CHU Pontchaillou /Hopital Sud Service de Neurologie
RECRUITING

Rennes, Brittany Region, 35033, France
CHU Strasbourg Hopital de Hautepierre
RECRUITING

Strasbourg, France
Charing Cross Hospital
RECRUITING

London, United Kingdom
Chattanooga Center for Neurologic Research
RECRUITING

Chattanooga, Tennessee, 37404-1163, United States
Chru Nancy Hopital Central
RECRUITING

Nancy, 54035, France
Clinique St Pierre
RECRUITING

Ottignies, 1340, Belgium
Elias Emergency University Hospital
RECRUITING

Bucharest, 011461, Romania
Emory University/Grady Memorial Hospital
RECRUITING

Atlanta, Georgia, 30303, United States
Erlanger Hospital
RECRUITING

Chattanooga, Tennessee, 37403, United States
Fundeni Clinical Institute
RECRUITING

Bucharest, Bucharest (Sector 2), 022328, Romania
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
RECRUITING

Glendale, California, 91206-4152, United States
Gulf Health Hospitals d/b/a Thomas Hospital
RECRUITING

Fairhope, Alabama, 36532, United States
HCA Florida - JFK Medical Center
RECRUITING

Atlantis, Florida, 33462-1149, United States
Hamilton Health Sciences - Hamilton General Hospital
RECRUITING

Hamilton, Ontario, L8L8E7, Canada
Health Sciences North
RECRUITING

Hamilton, Ontario, L8L2X2, Canada
Holy Cross Health
RECRUITING

Fort Lauderdale, Florida, 33308, United States
Hopital Pellegrin CHU Bordeaux
RECRUITING

Bordeaux, 33076, France
Hospital Clínico Universitario de Santiago
RECRUITING

Santiago de Compostela, 15706, Spain
Hospital Universitari Vall d'Hebron-Institut de Recerca
RECRUITING

Barcelona, 8035, Spain
Hospital Universitario Germans Trias i Pujol
RECRUITING

Badalona, 8916, Spain
Houston Methodist Neurological Institute
RECRUITING

Houston, Texas, 77030, United States
Imeldaziekenhuis (Imelda Hospital)
RECRUITING

Bonheiden, 015 50 50 11, Belgium
Instituto de Investigacion Biomedica de A Coruna (INIBIC)
RECRUITING

A Coruña, 15006, Spain
Israel-Georgia Medical Research Clinic-Healthycore LTD
ACTIVE_NOT_RECRUITING

Tbilisi, 0112, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
ACTIVE_NOT_RECRUITING

Tbilisi, 0159, Georgia
James Cook University Hospital
NOT_YET_RECRUITING

Middlesbrough, United Kingdom
Jessa Ziekenhuis
RECRUITING

Hasselt, 3500, Belgium
Kaiser Permanente Los Angeles Medical Center
RECRUITING

Los Angeles, California, 90027-5209, United States
Leeds Teaching Hospitals NHS Trust
NOT_YET_RECRUITING

Leeds, United Kingdom
Memorial Hermann Hospital, Texas Medical Center
RECRUITING

Houston, Texas, 77030, United States
Memorialcare Long Beach Medical Center
RECRUITING

Torrance, California, 90806, United States
Mercy Health - St. Vincent Medical Center
RECRUITING

Toledo, Ohio, 43608, United States
Military Institute of Medicine - National Research Institute
RECRUITING

Warsaw, Poland
New Hospitals LTD
ACTIVE_NOT_RECRUITING

Tbilisi, 0114, Georgia
North Buda St. John Central Hospital
NOT_YET_RECRUITING

Budapest, Hungary
Northwell Health Physician Partners - Neurology at Lenox Hill
RECRUITING

New York, New York, 10075, United States
Nottingham University Hospital
RECRUITING

Nottingham, United Kingdom
OSF HealthCare Saint Francis Medical Center
RECRUITING

Peoria, Illinois, 61637, United States
Ochsner Clinic Foundation
RECRUITING

New Orleans, Louisiana, 70121, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Petz Aladár County Teaching Hospital
RECRUITING

Győr, Vasvári Pál U. 2-4, 9024, Hungary
Pineo Medical Ecosystem LTD
ACTIVE_NOT_RECRUITING

Tbilisi, 0114, Georgia
Prisma Health-Greenville Memorial Hospital
RECRUITING

Greenville, South Carolina, 29605, United States
Ronald Reagan UCLA Medical Center
RECRUITING

Los Angeles, California, 90095, United States
Royal Devon and Exeter Hospital
RECRUITING

Exeter, Devon, EX25DW, United Kingdom
Royal Stoke University Hospital
RECRUITING

Stoke-on-Trent, ST4 6QG, United Kingdom
Sarasota Memorial Hospital
RECRUITING

Sarasota, Florida, 34239-2617, United States
St George's Hospital
RECRUITING

London, SW17 0QT, United Kingdom
St. Damjan Greek Catholic Hospital
RECRUITING

Kisvárda, 4600, Hungary
Stanford Health Care
RECRUITING

Stanford, California, 94305, United States
Summa Health Clinical Research Center
RECRUITING

Akron, Ohio, 44304, United States
Sunnybrook Research Institute
RECRUITING

North York, Ontario, M4N 3M5, Canada
Szpital Czerniakowski Warsaw
RECRUITING

Warsaw, Poland
Tampa General Hospital (TGH) - The Stroke Center
RECRUITING

Tampa, Florida, 33606-3603, United States
The Clinical Neuroscience Institute
RECRUITING

Dayton, Ohio, 45431, United States
The Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
The Lundquist Institute at Harbor UCLA Medical Center
RECRUITING

Torrance, California, 90502, United States
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
RECRUITING

Newcastle upon Tyne, England, NE1 4LP, United Kingdom
The University of New Mexico - School of Medicine
RECRUITING

Albuquerque, New Mexico, 87131, United States
The University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Trinity Health Grand Rapids Hospital
RECRUITING

Grand Rapids, Michigan, 49503, United States
UCM, Katowice
RECRUITING

Katowice, Poland
UMASS Chan Medical School
RECRUITING

Worcester, Massachusetts, 01655, United States
USC Arcadia Hospital
RECRUITING

Arcadia, California, 91007, United States
UZ Gent
RECRUITING

Ghent, 9000, Belgium
University College of London
RECRUITING

London, United Kingdom
University Hospital in Krakow
RECRUITING

Krakow, Poland
University Hospital of Zielona Góra
RECRUITING

Zielona Góra, Poland
University Medical Center of Southern Nevada
RECRUITING

Las Vegas, Nevada, 89102, United States
University of Alberta Hospital
RECRUITING

Edmonton, Alberta, T6G 2G3 7802481660, Canada
University of Florida Jacksonville
RECRUITING

Jacksonville, Florida, 32209, United States
Vancouver General Hospital
RECRUITING

Vancouver, British Columbia, V5Z1M9, Canada
Victoria Hospital- NHS Fife- Scotland- UK
RECRUITING

Kirkcaldy, United Kingdom
West Georgia Medical Center LTD
ACTIVE_NOT_RECRUITING

Kutaisi, 4600, Georgia

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