Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Start Date
11/7/2021
Completion Date
12/1/2026
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.
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.
Eligibility Criteria
Age Range: 18 years to 90 years
Interventions
Recombinant human tissue kallikrein
Placebo for DM199 Solution for Injection
Conditions
Locations
Gulf Health Hospitals d/b/a Thomas Hospital
Fairhope, Alabama 36532
United States
USC Arcadia Hospital
Arcadia, California 91007
United States
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Glendale, California 91206-4152
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027-5209
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Stanford Health Care
Stanford, California 94305
United States
The Lundquist Institute at Harbor UCLA Medical Center
Torrance, California 90502
United States
Memorialcare Long Beach Medical Center
Torrance, California 90806
United States
HCA Florida - JFK Medical Center
Atlantis, Florida 33462-1149
United States
Boca Raton Regional Hospital Marcus Neuroscience Institute
Boca Raton, Florida 33486
United States
Holy Cross Health
Fort Lauderdale, Florida 33308
United States
University of Florida Jacksonville
Jacksonville, Florida 32209
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239-2617
United States
Tampa General Hospital (TGH) - The Stroke Center
Tampa, Florida 33606-3603
United States
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois 61637
United States
Ascension Via Christi Hospitals Wichita Inc.
Wichita, Kansas 67214
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
UMASS Chan Medical School
Worcester, Massachusetts 01655
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United States
The University of New Mexico - School of Medicine
Albuquerque, New Mexico 87131
United States
Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York 10075
United States
Summa Health Clinical Research Center
Akron, Ohio 44304
United States
The Clinical Neuroscience Institute
Dayton, Ohio 45431
United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Ascension St. John
Tulsa, Oklahoma 74104
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Prisma Health-Greenville Memorial Hospital
Greenville, South Carolina 29605
United States
Erlanger Hospital
Chattanooga, Tennessee 37403
United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee 37404-1163
United States
Houston Methodist Neurological Institute
Houston, Texas 77030
United States
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas 77030
United States
Imeldaziekenhuis (Imelda Hospital)
Bonheiden, Belgium 015 50 50 11
Belgium
UZ Gent
Ghent, Belgium 9000
Belgium
Jessa Ziekenhuis
Hasselt, Belgium 3500
Belgium
AZ Groeninge
Kortrijk, Belgium 8500
Belgium
Clinique St Pierre
Ottignies, Belgium 1340
Belgium
University of Alberta Hospital
Edmonton, Alberta T6G 2G3 7802481660
Canada
Vancouver General Hospital
Vancouver, British Columbia V5Z1M9
Canada
Health Sciences North
Hamilton, Ontario L8L2X2
Canada
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario L8L8E7
Canada
Sunnybrook Research Institute
North York, Ontario M4N 3M5
Canada
CHU Pontchaillou /Hopital Sud Service de Neurologie
Rennes, Brittany Region 35033
France
West Georgia Medical Center LTD
Kutaisi, Georgia 4600
Georgia
Israel-Georgia Medical Research Clinic-Healthycore LTD
Tbilisi, Georgia 0112
Georgia
New Hospitals LTD
Tbilisi, Georgia 0114
Georgia
Pineo Medical Ecosystem LTD
Tbilisi, Georgia 0114
Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia 0159
Georgia
Bajcsy-Zsilinszky Hospital
Budapest, Hungary 1106
Hungary
St. Damjan Greek Catholic Hospital
Kisvárda, Hungary 4600
Hungary
B.-A.-Z. County Central Hospital
Miskolc, Hungary 3526
Hungary
Petz Aladár County Teaching Hospital
Győr, Vasvári Pál U. 2-4 9024
Hungary
Fundeni Clinical Institute
Bucharest, Bucharest (Sector 2) 022328
Romania
Elias Emergency University Hospital
Bucharest, Romania 011461
Romania
Instituto de Investigacion Biomedica de A Coruna (INIBIC)
A Coruña, Spain 15006
Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Spain 8916
Spain
Hospital Universitari Vall d'Hebron-Institut de Recerca
Barcelona, Spain 8035
Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain 15706
Spain
Royal Devon and Exeter Hospital
Exeter, Devon EX25DW
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
Newcastle upon Tyne, England NE1 4LP
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom CB2 0QQ
United Kingdom
St George's Hospital
London, United Kingdom SW17 0QT
United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom ST4 6QG
United Kingdom