All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

This study, called ReMEDy2, is looking at a new medicine called DM199 (rinvecalinase alfa) for people who have had a recent ischaemic stroke. This is the most common type of stroke, caused by a blood clot blocking blood flow to the brain. The study is for people with a moderate stroke who received treatment within 24 hours of their stroke starting. It's particularly for those who haven't had, or can't have, other common stroke treatments like clot-busting drugs (fibrinolytics) or clot removal (mechanical thrombectomy), or whose symptoms haven't improved much after these treatments. Experts will compare DM199 to a dummy medicine (placebo) to see if it's safe and effective. Participants will be involved for about 90 days.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
DiaMedica Therapeutics Inc
Enrolment target
728
Start
07 Nov 2021
Estimated completion
01 Dec 2026

What is this study about?

This study, called the ReMEDy2 Trial, is investigating a new medicine named DM199 for people who have recently experienced an ischaemic stroke. An ischaemic stroke happens when a blood clot blocks blood flow to part of the brain. The study is particularly focused on individuals who've had a moderate stroke and received treatment within 24 hours of symptoms appearing. It's especially for those who might not have many other treatment choices, or whose symptoms haven't improved significantly after their initial treatments.

Researchers want to understand if DM199 can safely help people recover better from this type of stroke. They will be comparing DM199 with a 'placebo', which looks like the medicine but doesn't contain any active drug. This is a common way to test new treatments, as it helps doctors see if any improvements are genuinely due to the study medicine. The study won't stop you from getting standard stroke care if that's what you need.

The study is being carried out in two main parts (Phase 2 and Phase 3) to thoroughly check the medicine's safety and how well it works. Up to 728 people might take part across many hospitals in different locations. Participants will be looked after for about 90 days after starting the treatment.

Key takeaways

  • Tests a new medicine (DM199) for ischaemic stroke.
  • Aims to improve recovery for people with moderate stroke, especially those with fewer other options.
  • Compares DM199 to a placebo (dummy medicine).
  • Requires treatment to start within 24 hours of stroke onset.
  • Participation lasts about 3 months.
  • You can still receive standard stroke care.

Who may be eligible?

This study is looking for adults aged between 18 and 90 years old who have had an ischaemic stroke recently. You need to have received treatment for your stroke within 24 hours of it starting. Your stroke symptoms should be moderate, not too mild or too severe. Before your stroke, you should have been generally healthy and able to care for yourself without much help.

There are also specific situations where you might be considered. For example, if you initially had milder symptoms but they got worse, or if you had clot-busting treatment but your stroke symptoms didn't improve much after at least six hours, and you still have moderate symptoms. Importantly, you shouldn't have had a brain bleed (haemorrhagic stroke) and you shouldn't be eligible for, or have had, mechanical thrombectomy (a procedure to remove a large clot).

If you're interested, you and/or your legal representative must be able to understand the study and agree to take part. You also need to be willing to follow the study's instructions. Your doctor will carefully check if you meet all the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 90 years old?
  2. Did your stroke symptoms start within the last 24 hours?
  3. Is your stroke an 'ischaemic stroke' (caused by a clot)?
  4. Do you have moderate stroke symptoms?
  5. Have you NOT had a bleeding stroke?
  6. Were you generally healthy before your stroke (able to manage daily life independently)?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly assigned to either receive the study medicine, DM199, or a placebo (a dummy medicine). You won't know which one you're getting, and neither will your care team. DM199 is given in two ways: first, as a single dose into a vein, and then as injections under the skin twice a week for up to 21 days.

Throughout the study, you'll have regular check-ups and assessments to monitor your health, how your stroke is recovering, and to check for any side effects. This will involve visits to the hospital or clinic. Your participation in the study from the first treatment to the final assessments will last for approximately 90 days (about three months).

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that DM199 might help you recover better from your stroke than standard care alone, especially if you have limited other treatment options. Potential risks could include side effects from the medicine, or the inconvenience of extra appointments and tests. However, the study is carefully designed to monitor your safety at all times. You have the right to withdraw from the study at any point, for any reason, without it affecting your medical care.

Locations (66)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Gulf Health Hospitals d/b/a Thomas Hospital
    Verified postcode
    Fairhope, United States· Recruiting
  • USC Arcadia Hospital
    Verified postcode
    Arcadia, United States· Recruiting
  • Glendale Adventist Medical Center d/b/a Adventist Health Glendale
    Verified postcode
    Glendale, United States· Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Ronald Reagan UCLA Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Stanford Health Care
    Verified postcode
    Stanford, United States· Recruiting
  • The Lundquist Institute at Harbor UCLA Medical Center
    Verified postcode
    Torrance, United States· Recruiting
  • Memorialcare Long Beach Medical Center
    Verified postcode
    Torrance, United States· Recruiting
  • HCA Florida - JFK Medical Center
    Verified postcode
    Atlantis, United States· Recruiting
  • Boca Raton Regional Hospital Marcus Neuroscience Institute
    Verified postcode
    Boca Raton, United States· Recruiting
  • Holy Cross Health
    Verified postcode
    Fort Lauderdale, United States· Recruiting
  • University of Florida Jacksonville
    Verified postcode
    Jacksonville, United States· Recruiting

Common questions

What kind of stroke is this study for?

This study is for ischaemic stroke, which is caused by a blood clot blocking blood flow to part of the brain.

Will I know if I'm getting the real medicine or a dummy medicine?

No, neither you nor your doctors will know if you're getting DM199 or the placebo. This helps make the study results fair.

How long will I be involved in the study?

Your involvement in the study will last for about 90 days (three months) from when you start treatment.

Can I still get normal stroke treatments if I join this study?

Yes, this study is designed so you can still receive standard stroke treatments if your doctors decide they are appropriate for you.

What if I change my mind about taking part?

You can withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Kayla Slupek

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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