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RECRUITING
NCT05065216
PHASE2/PHASE3

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

Sponsor: DiaMedica Therapeutics Inc

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

728

Start Date

2021-11-07

Completion Date

2026-12

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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

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.

Locations (63)

Gulf Health Hospitals d/b/a Thomas Hospital

Fairhope, Alabama, United States

USC Arcadia Hospital

Arcadia, California, United States

Glendale Adventist Medical Center d/b/a Adventist Health Glendale

Glendale, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Stanford Health Care

Stanford, California, United States

The Lundquist Institute at Harbor UCLA Medical Center

Torrance, California, United States

Memorialcare Long Beach Medical Center

Torrance, California, United States

HCA Florida - JFK Medical Center

Atlantis, Florida, United States

Holy Cross Health

Fort Lauderdale, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Tampa General Hospital (TGH) - The Stroke Center

Tampa, Florida, United States

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, United States

Ascension Via Christi Hospitals Wichita Inc.

Wichita, Kansas, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

UMASS Chan Medical School

Worcester, Massachusetts, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

The University of New Mexico - School of Medicine

Albuquerque, New Mexico, United States

Northwell Health Physician Partners - Neurology at Lenox Hill

New York, New York, United States

Summa Health Clinical Research Center

Akron, Ohio, United States

The Clinical Neuroscience Institute

Dayton, Ohio, United States

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Ascension St. John

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Prisma Health-Greenville Memorial Hospital

Greenville, South Carolina, United States

Erlanger Hospital

Chattanooga, Tennessee, United States

Chattanooga Center for Neurologic Research

Chattanooga, Tennessee, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, United States

Imeldaziekenhuis (Imelda Hospital)

Bonheiden, Belgium, Belgium

UZ Gent

Ghent, Belgium, Belgium

Jessa Ziekenhuis

Hasselt, Belgium, Belgium

AZ Groeninge

Kortrijk, Belgium, Belgium

Clinique St Pierre

Ottignies, Belgium, Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Health Sciences North

Hamilton, Ontario, Canada

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, Canada

Sunnybrook Research Institute

North York, Ontario, Canada

West Georgia Medical Center LTD

Kutaisi, Georgia, Georgia

Israel-Georgia Medical Research Clinic-Healthycore LTD

Tbilisi, Georgia, Georgia

New Hospitals LTD

Tbilisi, Georgia, Georgia

Pineo Medical Ecosystem LTD

Tbilisi, Georgia, Georgia

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia, Georgia

Bajcsy-Zsilinszky Hospital

Budapest, Hungary, Hungary

St. Damjan Greek Catholic Hospital

Kisvárda, Hungary, Hungary

B.-A.-Z. County Central Hospital

Miskolc, Hungary, Hungary

Petz Aladár County Teaching Hospital

Győr, Vasvári Pál U. 2-4, Hungary

Fundeni Clinical Institute

Bucharest, Bucharest (Sector 2), Romania

Elias Emergency University Hospital

Bucharest, Romania, Romania

Instituto de Investigacion Biomedica de A Coruna (INIBIC)

A Coruña, Spain, Spain

Hospital Universitario Germans Trias i Pujol

Badalona, Spain, Spain

Hospital Universitari Vall d'Hebron-Institut de Recerca

Barcelona, Spain, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain, Spain

Royal Devon and Exeter Hospital

Exeter, Devon, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom, United Kingdom

St George's Hospital

London, United Kingdom, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom, United Kingdom