Your session is about to expire
← Back to Search
Enzyme
Tissue Kallikrein for Ischemic Stroke (ReMEDy2 Trial)
Phase 2 & 3
Recruiting
Led By Scott Kasner, MD
Research Sponsored by DiaMedica Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is ≥18 years of age.
Participant is ≥18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1, day 4, day 21, day 30, and day 90
Awards & highlights
ReMEDy2 Trial Summary
This trial is testing a new drug to treat strokes when other treatments are not possible. The trial will be conducted at 75 centers across the United States.
Who is the study for?
Adults over 18, weighing between 50-160 kg, who've had an Acute Ischemic Stroke within the last 24 hours but can't have clot-dissolving drugs or mechanical clot removal. They should have a moderate stroke severity score and be in good health before the stroke. Pregnant women and those on certain blood pressure meds are excluded.Check my eligibility
What is being tested?
The ReMEDy2 Trial is testing DM199 (recombinant human tissue kallikrein) for safety and effectiveness in treating strokes when standard treatments aren't suitable. Participants will either receive DM199 or a placebo at random, without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects of DM199 may include allergic reactions like angioedema or anaphylaxis, changes in blood pressure levels, and potential issues with infection management due to its mechanism of action.
ReMEDy2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am 18 years old or older.
Select...
My weight is between 50 kg and 160 kg.
ReMEDy2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 1, day 4, day 21, day 30, and day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1, day 4, day 21, day 30, and day 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Causality of adverse events during treatment with DM199 or placebo
Causality of adverse events of special interest (AESI) during treatment with DM199 or placebo
Causality of serious adverse events during treatment with DM199 or placebo
+66 moreSecondary outcome measures
Assessment of effect on disability across the full spectrum of AIS by examining the distribution of Modified Rankin Scores (mRS)
Assessment of patients who experience recurrent stroke
Immunogenicity
+5 moreReMEDy2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DM199Experimental Treatment1 Intervention
DM199 administered by a single intravenous (IV) dose followed by a subcutaneous (SC) dose within 12 hours and then 2 times a week for three weeks (until Day 21).
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered by a single intravenous (IV) dose followed by a subcutaneous (SC) dose within 12 hours and then 2 times a week for three weeks (until Day 21).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recombinant human tissue kallikrein
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
DiaMedica Therapeutics IncLead Sponsor
5 Previous Clinical Trials
338 Total Patients Enrolled
2 Trials studying Stroke
128 Patients Enrolled for Stroke
Harry Alcorn, PharmDStudy DirectorDiaMedica Inc.
1 Previous Clinical Trials
23 Total Patients Enrolled
Scott Kasner, MDPrincipal InvestigatorUni Penn
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not eligible for molecular targeted therapy.You are expected to live for less than a year before the study starts.I am 18 years old or older.I have not been part of a drug study or taken experimental drugs in the last 30 days.I am 18 years old or older.I have alpha 1-antitrypsin deficiency.My weight is between 50 kg and 160 kg.You have a blockage in a large blood vessel in specific areas that is causing symptoms.I am taking an ACE inhibitor and cannot or do not want to switch to another blood pressure medicine until Day 29 ±1 day.Your blood pressure is too low after having a stroke.I am currently hospitalized or need IV treatment for an infection.I have trouble with veins for receiving treatment or drawing blood.My treatment for stroke will start within 24 hours of my last normal health state.I have received or will receive clot-dissolving medication for my stroke.You have a certain level of stroke severity, between 5 and 15, at the time of randomization.I have symptoms or imaging results that suggest a stroke in the back part of my brain.I am willing and able to follow all study requirements.You have any signs of bleeding inside your head.I am receiving or will receive mechanical thrombectomy for my stroke.You have a large area of dead tissue in your brain.I cannot receive tPA treatment due to timing or other medical reasons.I was diagnosed with an acute ischemic stroke less than a day ago.You have a National Institutes of Health Stroke Scale (NIHSS) score between 5 and 20.Patient and/or legally authorized representative is able to participate in the informed consent process.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: DM199
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial more prevalent in North America than in other continents?
"Patients can enrol at any of the 18 different recruitment sites, which include the Parkview Research Center in Fort Wayne, Indiana, McLaren Macomb Hospital in Flint, Michigan, and St. Mary's Hospital and Regional Medical Center - St. Mary's Neurology Clinic in Grand Junction, Colorado."
Answered by AI
What are researchers measuring in this clinical trial?
"The aim of this study is to monitor glucose levels over a period of 90 days. Secondary outcomes include PD as assessed by plasma MMP-9 levels, the proportion of patients achieving an excellent functional independence as measured by the Barthel Index, and the proportion of patients receiving an excellent neurological outcome as measured by the NIHSS."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
What site did they apply to?
Washington Regional Medical Center
Ascension St. John
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger