Acute StrokePhase 2/3ReMEDy2NCT05065216
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
A Phase 2/3 study testing Recombinant human tissue kallikrein in people with Acute Stroke and Ischemic Stroke, run by DiaMedica Therapeutics Inc at 86 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Stroke
- What is being tested?
- Recombinant human tissue kallikrein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 728 participants
- Where
- 86 sitesin 10 countries
- Study dates
- 7 Nov 2021to Dec 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is between 18 and 90 years of age inclusive.
- Participant weight is 40 kg to 166 kg inclusive.
- Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.
- 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.
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- Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative.
- 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.
- Participant and/or legally authorized representative is able to provide informed consent.
- Participant is willing and able to comply with the study protocol, in the Investigator's judgment.
Who cannot join
- At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke.
- 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).
- Participant has large core of established infarction defined as ASPECTS 0-5.
- Participant has or will receive MT for their current AIS.
- Participant has suspected or confirmed extracranial arterial dissection.
- 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.
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- 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.
- 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).
- 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.
- Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization.
- 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.
- Life expectancy estimated at ≤1 year prior to enrollment.
- 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).
- Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
- Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator.
- 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.
- 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.
- Participant does not have sufficient venous access for infusion of study treatment or blood sampling.
- Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
Trial locations and contacts
86 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
86 sites in 10 countries
United States36 sites, 36 recruiting
- Recruiting
Summa Health Clinical Research Center
Akron, Ohio, 44304
Gregg Shreve, (330) 375- 3927, shreveg@summahealth.org
Madihah Hepburn
- Recruiting
The University of New Mexico - School of Medicine
Albuquerque, New Mexico, 87131
Maryam Hosseini, MD, MHosseini@salud.unm.edu
- Recruiting
USC Arcadia Hospital
Arcadia, California, 91007
Rosalina Mayorga, 626-898-8322, rosalina.mayorga@med.usc.edu
Matthew Tenser
- Recruiting
Emory University/Grady Memorial Hospital
Atlanta, Georgia, 30303
Alicia Moore, 404-778-8239, alicia.escobar.moore@emory.edu
Dinesh Jillella
- Recruiting
HCA Florida - JFK Medical Center
Atlantis, Florida, 33462-1149
Mailer Fonseca, (561) 358-9998, Mailer.Fonseca@hcahealthcare.com
Teresita Casanova
- Recruiting
Boca Raton Regional Hospital Marcus Neuroscience Institute
Boca Raton, Florida, 33486
Margaret Scott Scott, 5619555784, mscott@baptisthealth.net
Thomas Hammond, M.D.
- Recruiting
Erlanger Hospital
Chattanooga, Tennessee, 37403
Mounzer Yassin-Kassab, MD, Mounzer.Kassab@erlanger.org
- Recruiting
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37404-1163
Thomas Devlin, M.D., (423) 648-0304, devlinmdphd@gmail.com
Thomas Devlin, M.D.
- Recruiting
The Clinical Neuroscience Institute
Dayton, Ohio, 45431
Madison Davis, 937-208-3689, mldavis@premierhealth.com
Bradley Jacobs
- Recruiting
Gulf Health Hospitals d/b/a Thomas Hospital
Fairhope, Alabama, 36532
Richard Friedman, M.D., 251-435-2400, rhonda.dickinson@infirmaryhealth.org
Richard Friedman, M.D.
- Recruiting
Holy Cross Health
Fort Lauderdale, Florida, 33308
Ashley Jean-Joseph, 954-542-8554, ashley.jean-joseph@holy-cross.com
Andrey Lima, M.D.
- Recruiting
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Glendale, California, 91206-4152
Lance J Lee, MD, +1 818-243-1501, lancelee@charter.net
Lance J Lee, MD
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Muhammad Farooq, MD, (616) 916-6151, farooqmu@trinity-health.org
- Recruiting
Prisma Health-Greenville Memorial Hospital
Greenville, South Carolina, 29605
Thompson Durham, 8646089207, Thompson.Durham@prismahealth.org
Sanjeev Sivakumar, M.D.
- Recruiting
Houston Methodist Neurological Institute
Houston, Texas, 77030
Rajan Gadhia, M.D, (713) 363-9065, rrgadhia@houstonmethodist.org
David McCane, (713) 441-5801, dmccane@houstonmethodist.org
- Recruiting
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, 77030
Andrew Barretto, M.D., (713) 500-7066, prasen.r.marella@uth.tmc.edu
Meghana Kasana, (713) 500-5719, meghana.kasana@uth.tmc.edu
- Recruiting
University of Florida Jacksonville
Jacksonville, Florida, 32209
Yasmeen Shabbir, 9042449856, Yasmeen.Shabbir@jax.ufl.edu
Benjamin Alwood, M.D.
- Recruiting
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Robert Panganiban, 17023837336, robert.panganiban@umcsn.com
Albert Cook, M.D.
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027-5209
Shayandokht Taleb, M.D., (323) 783-7387, shayandokht.x.taleb@kp.org
Shayandokht Taleb, M.D.
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Ileana Grunberg, (888) 888-8888, igrunberg@mednet.ucla.edu
Jeffery Saver, M.D.
- Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Ganesh Asaithambi, M.D., 612-863-0376, marie.meyer@allina.com
Ganesh Asaithambi, M.D.
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Jessica Henry, (504) 842-8627, jehenry@ochsner.org
Lauren Dunn, M.D.
- Recruiting
Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York, 10075
Salman Azhar, MD, sazhar@lmcmc.com
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Jorge Ortiz Garcia, M.D., (405) 271-4113, jorge-ortizgarcia@ouhsc.edu
Jorge Ortiz Garcia, M.D.
- Recruiting
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61637
Arun Talkad, M.D., (309) 624-7552, arun.v.talkad@osfhealthcare.org
Arun Talkad, M.D.
- Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nichole Gallatti, +1 215-349-8651, nichole.gallatti@pennmedicine.upenn.edu
Steven Messe, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Rachel Laursen, M.D., (503) 494-7225, laursen@ohsu.edu
Rachel Laursen, M.D.
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239-2617
Mauricio Concha, M.D., (941) 330-1864, mconcha@intercoastalmedical.com
Mauricio Concha, M.D.
- Recruiting
Stanford Health Care
Stanford, California, 94305
Nhi Nguyen, (650) 723-6469, nhiquero@stanford.edu
Christina Mijalski, M.D.
- Recruiting
Tampa General Hospital (TGH) - The Stroke Center
Tampa, Florida, 33606-3603
David Rose, MD, drose1@health.usf.edu
David Rose, MD
- Recruiting
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
Osama Zaidat, MD, (419) 251-3232, oozaidat@mercy.com
- Recruiting
The Lundquist Institute at Harbor UCLA Medical Center
Torrance, California, 90502
Alleana Marie Mendoza, (310)803-5687, AlleanaMarie.Mendoza@lundquist.org
Bijal Mehta, M.D.
- Recruiting
Memorialcare Long Beach Medical Center
Torrance, California, 90806
Nima Ramezan-Arab, MD, (562) 430-4513, nramezan@gmail.com
- Recruiting
Ascension St. John
Tulsa, Oklahoma, 74104
Errol Gordon, MD, Errol.Gordon@ascension.org
Errol Gordon, MD
- Recruiting
Ascension Via Christi Hospitals Wichita Inc.
Wichita, Kansas, 67214
Toni Sadler, 316-268-5932, Toni.Sadler@ascension.org
James Walker, M.D.
- Recruiting
UMASS Chan Medical School
Worcester, Massachusetts, 01655
Nimmy Francis, 508-856-4677, nimmy.francis@umassmemorial.org
Brian Silver, M.D.
United Kingdom12 sites, 12 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Francis Jobbin, 00 44 12 233 48532, jobbin.francis@nhs.net
Mathilde Pauls, M.D.
- Recruiting
Royal Devon and Exeter Hospital
Exeter, Devon, EX25DW
Lindsay Wilkes, (+44) 13 92 406 289, lindsaywilkes@nhs.net
Salim Elyas, M.D.
- Recruiting
Victoria Hospital- NHS Fife- Scotland- UK
Kirkcaldy
Mandy Couser, 00441592 643 355, mandy.couser@nhs.scot
Vera Cvoro
- Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Michelle Farman, +44 (0)113 3922938, michelle.farman@nhs.net
Vasileios Papavasileiou
- Recruiting
St George's Hospital
London, United Kingdom, SW17 0QT
Rita Ghatala, (+44) 20 87 253 260, Ghatala.rita@stgeorges.nhs.uk
Liqun Zhang, M.D.
- Recruiting
Barts Health NHS Trust The Royal London Hospital
London
Esther Erumere, 0044 (0) 2035940626, e.erumere@nhs.net
Thomas Harrison
- Recruiting
Charing Cross Hospital
London
Vaishali Dave, 0044203 311 5049, vaishali.dave@nhs.net
Dheeraj Kalladka
- Recruiting
University College of London
London
Sabaa Obarey, (+44) 2031087705, sabaa.obarey@nhs.net
Richard Perry
- Not yet recruiting
James Cook University Hospital
Middlesbrough
Faye Robinson, (+44) 1642 850850, faye.robinson17@nhs.net
George Thomas
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
Newcastle upon Tyne, England, NE1 4LP
Michelle Fawcett, 0044 191 2820 317, m.fawcett@nhs.net
Anand Dixit, M.D.
- Recruiting
Nottingham University Hospital
Nottingham
Jo Wright, 0044115 9249924 ext. 80731, jo.wright9@nhs.net
Ashit Shetty
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Joanne Hiden, +44 1782-672730, Joanne.Hiden@uhnm.nhs.uk
Christine Roffe, M.D.
Belgium6 sites, 6 recruiting
- Recruiting
Imeldaziekenhuis (Imelda Hospital)
Bonheiden, Belgium, 015 50 50 11
Hannelore Vaneeckhaute, +32 15 50 50 11, hannelore.vaneeckhaute@imelda.be
Laurens Dobbels, M.D.
- Recruiting
UZ Gent
Ghent, Belgium, 9000
Wendy Stoop, 00 32 9 332 04 49, wendy.stoop@uzgent.be
Dimitri Hemelsoet
- Recruiting
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Eveline Swinnen, 00 32 11 33 78 76, eveline.swinnen@jessazh.be
Koen Delmotte, M.D.
- Recruiting
AZ Groeninge
Kortrijk, Belgium, 8500
Isabelle Vanpanteghem, 003256 63 34 49, isabelle.vanpanteghem@azgroeninge.be
Peter Vanacker, M.D.
- Recruiting
CHC Montléga
Liège, 4000
Karima Bouaassam, 0032 491623400, karima.bouaassam@chc.be
Philippe Desfontaines
- Recruiting
Clinique St Pierre
Ottignies, Belgium, 1340
Martine Gerard, 00 32 10 43 76 72, martine.gerard@cspo.be
Jean-Marc Raymackers, M.D.
Poland6 sites, 6 recruiting
- Recruiting
UCM, Katowice
Katowice
Karina Stelmaszak, 48695594469, stelmaszak1259@gmail.com
Magdalena Targosz-Gajniak
- Recruiting
University Hospital in Krakow
Krakow
Agnieszka Sikora, 124003321, agsikora@su.krakow.pl
Agnieszka Słowik
- Recruiting
Military Institute of Medicine - National Research Institute
Warsaw
Joanna Królewicz, 695670955, jkrolewicz@wim.mil.pl
Adam Stępień
- Recruiting
Szpital Czerniakowski Warsaw
Warsaw
Hanna Sęktas, 48223186386, neurologia@szpitalczerniakowski.waw.pl
Jarosław Pniewski
- Recruiting
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu
Wroclaw
Jakub Zublewicz, (+48) 501285906, jzublewicz@4wsk.pl
Bartłomiej Mielcarek
- Recruiting
University Hospital of Zielona Góra
Zielona Góra
Anita Nowak, (+48) 68 3000825, anita.nowak@szpital.zgora.pl
Szymon Jurga
Canada5 sites, 5 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2G3 7802481660
Ashfaq Shuaib, (780) 248-1927, danna.puchailo@albertahealthservices.ca
Danna Puchailo, (780) 248-1660, danna.puchailo@albertahealthservices.ca
- Recruiting
Health Sciences North
Hamilton, Ontario, L8L2X2
Mythili Velma, 705-523-7100 ext. 1932, mvelma@hsnri.ca
Ravinder Singh
- Recruiting
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, L8L8E7
Shuhira Himed, (905) 521-2100, himed@HHSC.CA
Kelvin Ng
- Recruiting
Sunnybrook Research Institute
North York, Ontario, M4N 3M5
Amanpreet Kaur, +14164806100, amanpreet.kaur1@sri.utoronto.ca
Richard Swartz, M.D.
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Carson Ma, 6048754111, carson.ma@vch.ca
Jonathan Gorman, M.D.
France5 sites, 5 recruiting
- Recruiting
Hopital Pellegrin CHU Bordeaux
Bordeaux, 33076
Sylvain Ledure, sylvain.ledure@chu-bordeaux.fr
Igor Sibon
- Recruiting
Aphm Hopital Timone
Marseille
Marie Elisabeth Fontaine, 0033 491 38 76 65, marie-elizabeth.fontaine@ap-hm.fr
Emilie Doche
- Recruiting
Chru Nancy Hopital Central
Nancy, 54035
Georges Valérie, 00 33 3 83 85 10 29, v.georges@chru-nancy.fr
Sébastien Richard
- Recruiting
CHU Pontchaillou /Hopital Sud Service de Neurologie
Rennes, Brittany Region, 35033
Francoise Kestens, 02.99.28.43.21 ext. 87123, Francoise.KESTENS@chu-rennes.fr
Stéphane Vannier, M.D.
- Recruiting
CHU Strasbourg Hopital de Hautepierre
Strasbourg
Matthieu Krug, 00 33 (0)3.88.12.86.16, matthieu.krug@chru-strasbourg.fr
Valérie Wolff
Georgia5 sites
- Active, not recruiting
West Georgia Medical Center LTD
Kutaisi, Georgia, 4600
- Active, not recruiting
Israel-Georgia Medical Research Clinic-Healthycore LTD
Tbilisi, Georgia, 0112
- Active, not recruiting
New Hospitals LTD
Tbilisi, Georgia, 0114
- Active, not recruiting
Pineo Medical Ecosystem LTD
Tbilisi, Georgia, 0114
- Active, not recruiting
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia, 0159
Hungary5 sites, 5 recruiting
- Recruiting
Bajcsy-Zsilinszky Hospital
Budapest, Hungary, 1106
Bernadett Bruckner, 00 36 30 195 3560, bruckner.bernadett@bajcsy.hu
Ildikó Vastagh, M.D.
- Not yet recruiting
North Buda St. John Central Hospital
Budapest
Regina Repper, 36202137943, repperregina0@gmail.com
Ferenc Fazekas
- Recruiting
Petz Aladár County Teaching Hospital
Győr, Vasvári Pál U. 2-4, 9024
Attila Csányi, M.D., +36303515954, csanyia77@gmail.com
Attila Csányi, M.D.
- Recruiting
St. Damjan Greek Catholic Hospital
Kisvárda, Hungary, 4600
Edit Muskóczki, 00 36 20 587 3232, muskoczkiedit@gmail.com
Marina Czurkó, M.D.
- Recruiting
B.-A.-Z. County Central Hospital
Miskolc, Hungary, 3526
Éva Kubiczki-Nagy, 00 36 70 409 8910, kubiczkinagyeva@gmail.com
Attila Valikovics, M.D.
Spain4 sites, 4 recruiting
- Recruiting
Instituto de Investigacion Biomedica de A Coruna (INIBIC)
A Coruña, Spain, 15006
Maria López Fernández, +34 981 17 81 50, Maria.Lopez.Fernandez@sergas.es
Maria del Mar Castellanos Rodrigo, M.D.
- Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Spain, 8916
Clara Expósito Guanter, 93 497 87 34, cexposito@igtp.cat
Marina Martínez Sánchez, M.D.
- Recruiting
Hospital Universitari Vall d'Hebron-Institut de Recerca
Barcelona, Spain, 8035
Lidia Garcia, (+34) 934893000, lidiavhir@gmail.com
Carlos Molina Cateriano, M.D.
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Susana Arias Rivas, +34 981 95 00 00, susanaarias2001@gmail.com
Manuel Rodriguez Yanez, M.D.
Romania2 sites, 2 recruiting
- Recruiting
Fundeni Clinical Institute
Bucharest, Bucharest (Sector 2), 022328
Claudia Ilincuta, +40 21 275 0500, ilincutaclaudia@yahoo.com
Octaviana - Adriana Dulămea, M.D.
- Recruiting
Elias Emergency University Hospital
Bucharest, Romania, 011461
Cristina Aura Panea, M.D., +40 21 316 1600, cristina.panea@umfcd.ro
cristina.panea@umfcd.ro
About this study
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)
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.
Read the 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.
- Conditions
- Acute Stroke, Ischemic Stroke, Stroke
- Being tested
- Recombinant human tissue kallikrein, Placebo for DM199 Solution for Injection
- Keywords
- acute, ischemic, stroke, AIS, tPA, LVO, MT, KLK1, Kallikreins
- Medical subject headings
- Stroke, Ischemic Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human tissue kallikreinDrug
Also called 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
Placebo for DM199 Solution for InjectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DM199 | Experimental | 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. Receives: Drug: Recombinant human tissue kallikrein |
| Placebo for DM199 Solution for Injection | Placebo comparator | 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. Receives: Other: Placebo for DM199 Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Recovery
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).
Measured: Day 90
Secondary outcomes (6)
Effect on Disability
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).
Measured: Day 90
Independent Function
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).
Measured: Day 90
Mortality Rate
Mortality rate as defined by event rate (%) for mortality over 90 days.
Measured: Day 90
Neurological Outcome
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.
Measured: Day 90
Functional Independence
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).
Measured: Day 90
AIS Recurrence
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.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start7 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DiaMedica Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Volpi, M.D., Principal investigator, The Methodist Hospital Research InstituteRachel Laursen, M.D., Principal investigator, Oregon Health & Science University (OHSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065216
- Sponsor's protocol ID
- DM199-2021-001
- Acronym
- ReMEDy2
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No