RECRUITING

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2021-11-07
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05065216

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant is between 18 and 90 years of age inclusive.
  2. 2. Participant weight is 40 kg to 166 kg inclusive.
  3. 3. Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.
  4. 4. Participant has NIHSS ≥5 and ≤15 at approximately the time of randomization. This criterion also applies to participants who meet the following conditions:
  5. * 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
  6. * Participant meets all other inclusion and exclusion criteria, including repeat brain imaging to rule out hemorrhagic transformation.
  7. 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.
  8. 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:
  9. * Participant's initial NIHSS score prior to fibrinolytics was ≤15; and
  10. * At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and
  11. * The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and
  12. * Participant meets all other inclusion and exclusion criteria including repeat brain imaging to rule out hemorrhagic transformation.
  13. 7. Participant and/or legally authorized representative is able to provide informed consent.
  14. 8. Participant is willing and able to comply with the study protocol, in the Investigator's judgment.
  1. 1. At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke.
  2. 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. 3. Participant has large core of established infarction defined as ASPECTS 0-5.
  4. 4. Participant has or will receive MT for their current AIS.
  5. 5. Participant has suspected or confirmed extracranial arterial dissection.
  6. 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. 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. 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. 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. 10. Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization.
  11. 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. 12. Life expectancy estimated at ≤1 year prior to enrollment.
  13. 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.
  14. 14. Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
  15. 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. 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.
  17. * Combined (estrogen and progesterone containing) hormonal oral, intravaginal, or transdermal contraception associated with the inhibition of ovulation
  18. * Progesterone-only oral, injectable, or implantable hormonal contraception associated with the inhibition of ovulation
  19. * Intrauterine device (IUD)
  20. * Intrauterine hormone-releasing system (IUS)
  21. * Bilateral tubal occlusion
  22. * Vasectomized partner
  23. * 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.
  24. 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.
  25. 18. Participant does not have sufficient venous access for infusion of study treatment or blood sampling.
  26. 19. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
  27. 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.

Contacts and Locations

Study Contact

Kayla Slupek
CONTACT
(717)304-7442
kslupek@diamedica.com
Adrienne Ford
CONTACT
(717)658-6652
aford@diamedica.com

Principal Investigator

Scott Kasner, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Washington Regional Medical Center
Fayetteville, Arkansas, 72703
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
Memorialcare Long Beach Medical Center
Torrance, California, 90806
United States
HCA Florida - JFK Medical Center
Atlantis, Florida, 33462-1149
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
Community Hospital - MacArthur
Munster, Indiana, 46321-2901
United States
Medstar Franklin Square Medical Center
Baltimore, Maryland, 21237
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
SSM Health DePaul Hospital - St Louis
Bridgeton, Missouri, 63044
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
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
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Erlanger Hospital
Chattanooga, Tennessee, 37403
United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37404-1163
United States
Ballad Health
Johnson City, Tennessee, 37604
United States
Houston Methodist Neurological Institute
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: DiaMedica Therapeutics Inc

  • Scott Kasner, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Registration Dates

Study Start Date2021-11-07
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-11-07
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • acute
  • ischemic
  • stroke
  • AIS
  • tPA
  • LVO
  • MT
  • KLK1
  • Kallikreins

Additional Relevant MeSH Terms

  • Acute Stroke
  • Ischemic Stroke
  • Stroke