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Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Sponsor: DiaMedica Therapeutics Inc
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
Conditions
Interventions
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
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