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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.

Must not have

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 screening.

Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1, day 4, day 21, day 30, and day 90

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 18 years old or older.

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My weight is between 50 kg and 160 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been part of a drug study or taken experimental drugs in the last 30 days.

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I have alpha 1-antitrypsin deficiency.

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I am currently hospitalized or need IV treatment for an infection.

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I have trouble with veins for receiving treatment or drawing blood.

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I have received or will receive clot-dissolving medication for my stroke.

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I have symptoms or imaging results that suggest a stroke in the back part of my brain.

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I am receiving or will receive mechanical thrombectomy for my stroke.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1, day 4, day 21, day 30, and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

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

0 / 10Eligibility criteria met