BridgeMD
New treatment option for Acute Stroke
Official title Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
ClinicalTrials.gov ID: NCT05065216
What this study is testing
What is Recombinant human tissue kallikrein?
Recombinant human tissue kallikrein is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute stroke.
Also referred to as DM199.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Participant is between 18 and 90 years of age inclusive.
- Participant weight is 40 kg to 166 kg inclusive.
- Participant to be assigned by chance 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...
- The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution...
You likely can't join if
- , including repeat brain imaging to rule out hemorrhagic transformation.
- 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...
- 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
See the full eligibility criteria
Who can join
- Participant is between 18 and 90 years of age inclusive.
- Participant weight is 40 kg to 166 kg inclusive.
- Participant to be assigned by chance 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
What rules you out
- , including repeat brain imaging to rule out hemorrhagic transformation.
- 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...
- 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. Exclusion Criteria:
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fairhope, Alabama, United States
- Arcadia, California, United States
- Glendale, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- Torrance, California, United States
- Atlantis, Florida, United States
- Boca Raton, Florida, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Peoria, Illinois, United States
- Wichita, Kansas, United States
- New Orleans, Louisiana, United States
- Worcester, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairhope, Alabama, United States; Arcadia, California, United States; Glendale, California, United States; Los Angeles, California, United States; Stanford, California, United States; Torrance, California, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.