Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) (ReMEDy2)

April 23, 2026 updated by: DiaMedica Therapeutics Inc

Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 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 eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2/3 Adaptive Design, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial). Participants with AIS will be randomized 1:1 to DM199 or placebo. DM199 will be administered as a single intravenous (IV) dose (0.5 μg/kg; not to exceed 50 μg) followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21. The duration of each individual's participation in the study will be approximately 90 days from the time of initial treatment to completion of all study activities.

A formal interim analysis will be conducted after 200 participants complete their Day 90 assessment in Part A. The purposes of this interim analysis are to assess safety, allow early stopping of the study for futility, or continuing the study with a revised final sample up to a maximum of 728 participants.

Study Type

Interventional

Enrollment (Estimated)

728

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Belgium
      • Bonheiden, Belgium, Belgium, 015 50 50 11
        • Recruiting
        • Imeldaziekenhuis (Imelda Hospital)
        • Contact:
        • Principal Investigator:
          • Laurens Dobbels, M.D.
      • Ghent, Belgium, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Dimitri Hemelsoet
        • Contact:
      • Hasselt, Belgium, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Koen Delmotte, M.D.
      • Kortrijk, Belgium, Belgium, 8500
        • Recruiting
        • AZ Groeninge
        • Contact:
        • Principal Investigator:
          • Peter Vanacker, M.D.
      • Ottignies, Belgium, Belgium, 1340
        • Recruiting
        • Clinique St Pierre
        • Contact:
        • Principal Investigator:
          • Jean-Marc Raymackers, M.D.
  • Canada
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan Gorman, M.D.
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Recruiting
        • Health Sciences North
        • Contact:
        • Principal Investigator:
          • Ravinder Singh
      • Hamilton, Ontario, Canada, L8L8E7
        • Recruiting
        • Hamilton Health Sciences - Hamilton General Hospital
        • Principal Investigator:
          • Kelvin Ng
        • Contact:
          • Shuhira Himed
          • Phone Number: (905) 521-2100
          • Email: himed@HHSC.CA
      • North York, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
        • Contact:
        • Principal Investigator:
          • Richard Swartz, M.D.
  • France
    • Brittany Region
      • Rennes, Brittany Region, France, 35033
        • Recruiting
        • CHU Pontchaillou /Hopital Sud Service de Neurologie
        • Contact:
        • Principal Investigator:
          • Stéphane Vannier, M.D.
  • Georgia
    • Georgia
      • Kutaisi, Georgia, Georgia, 4600
        • Recruiting
        • West Georgia Medical Center LTD
        • Contact:
        • Principal Investigator:
          • Tamar Janelidze, M.D.
      • Tbilisi, Georgia, Georgia, 0112
        • Recruiting
        • Israel-Georgia Medical Research Clinic-Healthycore LTD
        • Contact:
        • Principal Investigator:
          • Zurabi Akhalaia, M.D.
      • Tbilisi, Georgia, Georgia, 0114
        • Recruiting
        • New Hospitals LTD
        • Contact:
        • Principal Investigator:
          • Temur Margania, M.D.
      • Tbilisi, Georgia, Georgia, 0114
        • Recruiting
        • Pineo Medical Ecosystem LTD
        • Contact:
        • Principal Investigator:
          • Nikoloz Tsiskaridze, M.D.
      • Tbilisi, Georgia, Georgia, 0159
        • Recruiting
        • JSC K. Eristavi National Center of Experimental and Clinical Surgery
        • Contact:
        • Principal Investigator:
          • Giorgi Egutidze, M.D.
  • Hungary
    • Hungary
      • Budapest, Hungary, Hungary, 1106
        • Recruiting
        • Bajcsy-Zsilinszky Hospital
        • Contact:
        • Principal Investigator:
          • Ildikó Vastagh, M.D.
      • Kisvárda, Hungary, Hungary, 4600
        • Recruiting
        • St. Damjan Greek Catholic Hospital
        • Contact:
        • Principal Investigator:
          • Marina Czurkó, M.D.
      • Miskolc, Hungary, Hungary, 3526
        • Recruiting
        • B.-A.-Z. County Central Hospital
        • Contact:
        • Principal Investigator:
          • Attila Valikovics, M.D.
    • Vasvári Pál U. 2-4
      • Győr, Vasvári Pál U. 2-4, Hungary, 9024
        • Recruiting
        • Petz Aladár County Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Attila Csányi, M.D.
  • Romania
    • Bucharest (Sector 2)
      • Bucharest, Bucharest (Sector 2), Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute
        • Contact:
        • Principal Investigator:
          • Octaviana - Adriana Dulămea, M.D.
    • Romania
      • Bucharest, Romania, Romania, 011461
  • Spain
    • Spain
      • A Coruña, Spain, Spain, 15006
        • Recruiting
        • Instituto de Investigacion Biomedica de A Coruna (INIBIC)
        • Contact:
        • Principal Investigator:
          • Maria del Mar Castellanos Rodrigo, M.D.
      • Badalona, Spain, Spain, 8916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Marina Martínez Sánchez, M.D.
      • Barcelona, Spain, Spain, 8035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Institut de Recerca
        • Contact:
        • Principal Investigator:
          • Carlos Molina Cateriano, M.D.
      • Santiago de Compostela, Spain, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
        • Principal Investigator:
          • Manuel Rodriguez Yanez, M.D.
  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX25DW
        • Recruiting
        • Royal Devon and Exeter Hospital
        • Contact:
        • Principal Investigator:
          • Salim Elyas, M.D.
    • England
      • Newcastle upon Tyne, England, United Kingdom, NE1 4LP
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
        • Contact:
        • Principal Investigator:
          • Anand Dixit, M.D.
    • United Kingdom
      • Cambridge, United Kingdom, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
        • Principal Investigator:
          • Mathilde Pauls, M.D.
      • London, United Kingdom, United Kingdom, SW17 0QT
        • Recruiting
        • St George's Hospital
        • Contact:
        • Principal Investigator:
          • Liqun Zhang, M.D.
      • Stoke-on-Trent, United Kingdom, United Kingdom, ST4 6QG
        • Recruiting
        • Royal Stoke University Hospital
        • Contact:
        • Principal Investigator:
          • Christine Roffe, M.D.
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • Gulf Health Hospitals d/b/a Thomas Hospital
        • Principal Investigator:
          • Richard Friedman, M.D.
        • Contact:
    • California
      • Arcadia, California, United States, 91007
        • Recruiting
        • USC Arcadia Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Tenser
      • Glendale, California, United States, 91206-4152
        • Recruiting
        • Glendale Adventist Medical Center d/b/a Adventist Health Glendale
        • Principal Investigator:
          • Lance J Lee, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffery Saver, M.D.
      • Los Angeles, California, United States, 90027-5209
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Principal Investigator:
          • Shayandokht Taleb, M.D.
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Care
        • Contact:
        • Principal Investigator:
          • Christina Mijalski, M.D.
      • Torrance, California, United States, 90806
        • Recruiting
        • MemorialCare Long Beach Medical Center
        • Contact:
      • Torrance, California, United States, 90502
        • Recruiting
        • The Lundquist Institute at Harbor UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Bijal Mehta, M.D.
    • Florida
      • Atlantis, Florida, United States, 33462-1149
        • Recruiting
        • HCA Florida - JFK Medical Center
        • Contact:
        • Principal Investigator:
          • Teresita Casanova
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Boca Raton Regional Hospital Marcus Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • Thomas Hammond, M.D.
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Health
        • Contact:
        • Principal Investigator:
          • Andrey Lima, M.D.
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Jacksonville
        • Contact:
        • Principal Investigator:
          • Benjamin Alwood, M.D.
      • Sarasota, Florida, United States, 34239-2617
        • Recruiting
        • Sarasota Memorial Hospital
        • Principal Investigator:
          • Mauricio Concha, M.D.
        • Contact:
      • Tampa, Florida, United States, 33606-3603
        • Recruiting
        • Tampa General Hospital (TGH) - The Stroke Center
        • Contact:
        • Principal Investigator:
          • David Rose, MD
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF HealthCare Saint Francis Medical Center
        • Principal Investigator:
          • Arun Talkad, M.D.
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi Hospitals Wichita Inc.
        • Contact:
        • Principal Investigator:
          • James Walker, M.D.
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Lauren Dunn, M.D.
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Chan Medical School
        • Contact:
        • Principal Investigator:
          • Brian Silver, M.D.
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Ganesh Asaithambi, M.D.
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • Albert Cook, M.D.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • The University of New Mexico - School of Medicine
        • Contact:
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health Physician Partners - Neurology at Lenox Hill
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Madihah Hepburn
      • Dayton, Ohio, United States, 45431
        • Active, not recruiting
        • The Clinical Neuroscience Institute
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Mercy Health - St. Vincent Medical Center
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Jorge Ortiz Garcia, M.D.
        • Contact:
      • Tulsa, Oklahoma, United States, 74104
        • Active, not recruiting
        • Ascension St. John
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Rachel Laursen, M.D.
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Hospital of the University of Pennsylvania
        • Principal Investigator:
          • Steven Messe, MD
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health-Greenville Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Sanjeev Sivakumar, M.D.
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
      • Chattanooga, Tennessee, United States, 37404-1163
        • Recruiting
        • Chattanooga Center for Neurologic Research
        • Principal Investigator:
          • Thomas Devlin, M.D.
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Hospital, Texas Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Barretto, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DM199
DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.
Drug: Recombinant human tissue kallikrein
DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21
Other Names:
  • DM199
Placebo Comparator: Placebo for DM199 Solution for Injection
Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.
Other: Placebo for DM199 Solution for Injection
Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Recovery
Time Frame: Day 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).
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on Disability
Time Frame: Day 90
Assessment of effect on disability across the full spectrum of AIS by examining the distribution of mRS (shift) scores (scale range = 0 to 6) at Day 90. 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).
Day 90
Independent Function
Time Frame: Day 90
Proportion of participants achieving independent function (able to look after their own affairs without assistance) with or without minor disability at Day 90 assessed as mRS 0-2 (dichotomized) mRS scores of 0, 1 or 2 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).
Day 90
Mortality Rate
Time Frame: Day 90
Mortality rate as defined by event rate (%) for mortality over 90 days.
Day 90
Neurological Outcome
Time Frame: Day 90

Proportion of participants achieving an excellent neurological outcome defined by National Institute of Health Stroke Scale (NIHSS)= 0-1 (dichotomized) (NIHSS scores of 0 or 1, scale range 0 to 42) at Day 90.

The National Institute of Health Stroke Scale (NIHSS) is a clinician-reported measure used to rate the severity of strokes, namely disability and recovery after acute stroke. The scale is comprised of 11 items with item scores ranging from 0 to 4. Total scores range from 0 to 42, with higher scores indicating increased severity.
Day 90
Functional Independence
Time Frame: Day 90

Proportion of participants achieving an excellent functional independence in activities of daily living defined by Barthel Index score (dichotomized) greater than or equal to 5 (scale range 0 to 100) at Day 90.

The Barthel Index (BI) is a 10-item scale assessing activities of daily living and functional disability. Each item is scored in increments of 5 points (0, 5, 10, or 15) and the individual items are summed to produce a total score between 0 and 100, with higher scores representing more optimal performance (100 = fully independent) and lower scores representing inferior performance (0 = totally dependent).
Day 90
AIS Recurrence
Time Frame: Day 90
Recurrent AIS as defined by proportion of participants who experience a recurrent AIS by Day 90 as assessed by a new, persistent neurological deficit attributable to cerebrovascular ischemia. Imaging findings, if available, should support the diagnosis.
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiaMedica Therapeutics Inc

Investigators

  • Principal Investigator: Jay Volpi, M.D., The Methodist Hospital Research Institute
  • Principal Investigator: Rachel Laursen, M.D., Oregon Health & Science University (OHSU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM199-2021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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