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ReMEDy2: 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

  • Status
    Accepting Candidates
  • Age
    18 Years - 90 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

This Study is testing the study drug to see if it can be used safely and effectively in people who have experienced an ischemic stroke in the past 24 hours and cannot take other approved treatments.

The study drug is a man-made form of an enzyme called kallikrein-1 (KLK1.) KLK1 causes the body to produce kinins, which are substances in the blood that widen blood vessels and improve blood flow in the brain. The study drug needs to be administered within 24 hours of the onset of stroke symptoms. 

 

After a study screening to check if patients are eligible they will be randomly assigned (like flipping a coin) to study treatment with either the study drug or placebo, an inactive substance. Comparing against a placebo is important to make sure that any changes seen during the study are due to the investigational drug alone and not another reason.

This first dose is administered as an intravenous infusion (IV) IN THE HOSPITAL. Subsequent doses will then be administered as a subcutaneous injection, which is an injection under the skin in the abdomen arm or thigh. 

Once patients are discharged the study drug injections will be given at either a rehab facility, the study doctor's clinic, or at their home by a caregiver or visiting nurses twice each week for the following 3 weeks. The study team will call patients or their caregiver or available healthcare provider to review the study drug injection process and to see how they are doing. There will be 2 final visits at 1 month and 2 moths after the end-of-study treatment for additional health checks. 

Details

Protocol number 20250035

Eligibility

- Be between 18 and 90 years old

- Have experienced an ischemic stroke that began within the past 24 hours

- be able to provide informed consent or have a legal representative (such as a family member) who can do so on their behalf. 

-Not be a candidate for approved mechanical thrombectomy (MT) or if treatment with fibrinolytic medication was unsuccessful. 

-if you are taking a high blood pressure medication called an ACE inhibitor, you should discuss with the study doctor before entering the study whether you can pause using it and if other medications may be prescribed or what other options may be available to you during the time you are in this study.

-Other criteria will also be reviewed to determine eligibility

Lead researchers

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Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.