Clinical trial 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 (DM199)?
An investigational medicine being studied for the treatment of acute ischemic 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
- The study wants to see if DM199 is safe and helps people with moderate strokes caused by small or medium vessel blockages.
- Who it's for
- Adults who have had a moderate ischemic stroke and can get to the hospital within 24 hours, but who are not getting clot‑removal surgery or clot‑breaking drugs unless they still have moderate symptoms after six hours.
- What's involved
- Participants will receive either DM199 or a placebo in a double‑blind, randomized design. They will have regular visits and tests to monitor safety and stroke recovery.
- Time commitment
- The study lasts about 90 days, with several clinic visits and tests during that time.
- 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.
- The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution...
- Participant meets all other inclusion and
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.
- 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.
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.
- 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.
- 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.
- 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.
- 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.
- 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 is enrolling
- 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
- Atlanta, Georgia, 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
+ 50 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, but 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?
This study is enrolling now at 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 64 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.