Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
728 participants
INTERVENTIONAL
2021-11-07
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant weight is 40 kg to 166 kg inclusive.
3. Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.
4. 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
Exclusion Criteria
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:
* 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
7. Participant and/or legally authorized representative is able to provide informed consent.
8. Participant is willing and able to comply with the study protocol, in the Investigator's judgment.
1. At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke.
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. Participant has large core of established infarction defined as ASPECTS 0-5.
4. Participant has or will receive MT for their current AIS.
5. Participant has suspected or confirmed extracranial arterial dissection.
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. 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. 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. 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. Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization.
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. Life expectancy estimated at ≤1 year prior to enrollment.
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.
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).
14. Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
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. 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.
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.
18. Participant does not have sufficient venous access for infusion of study treatment or blood sampling.
19. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
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.
18 Years
90 Years
ALL
No
Sponsors
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DiaMedica Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Volpi, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Rachel Laursen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oregon Health & Science University (OHSU)
Locations
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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
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
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
Community Hospital - MacArthur
Munster, Indiana, 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
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
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
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
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DM199-2021-001
Identifier Type: -
Identifier Source: org_study_id
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