Study of DM199 for the treatment of Acute Ischemic Stroke
Research type
Research Study
Full title
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 (ReMEDy2 Trial)
IRAS ID
1012079
Contact name
Rick Pauls
Contact email
Sponsor organisation
DiaMedica Therapeutics Inc.
Clinicaltrials.gov Identifier
Research summary
This is a phase 2/3 study and will assess the effectiveness and safety of study drug, DM199 for the treatment of Acute Ischemic Stroke (AIS). An AIS occurs when the blood vessels (arteries) that supply oxygen to a part of the brain become narrowed or blocked, which reduces or completely stops blood supply to that part of the brain. Currently, the approved treatments for AIS are limited & many patients may not be eligible for those treatment or they may be unsuccessful for those treatments.
To participate in the study, patients must have recently experienced an AIS for which thrombolytics and/or mechanical thrombectomy (MT) are not medically allowed, or if treatment with thrombolytics was allowed but was unsuccessful.
The Sponsor of this study DiaMedica Therapeutics Inc. has developed a new investigational drug, DM199, that is being studied for the treatment of AIS. DM199 is a synthetic (manmade) or recombinant (made in a laboratory) form of a protein called kallikrein-1 (KLK1). KLK1 is a protein, occurring naturally in the body, that has a natural ability to widen blood vessels & improve local blood flow in the brain. DM199 can be administered within 24 hours of stroke onset.
The total expected duration of the study is approximately 90 days (3 months). There will be a screening period (Day 1), study treatment period (Day 1 through Day 21) and safety follow up period (Day 30 and Day 90). If patients agree to participate and they have passed screening, they will receive either study drug or a placebo as a single intravenous infusion, which may take up to approximately 2 to 4 hours. After the IV infusion, 7 subcutaneous (SC) injections will be given under the skin in the abdomen, thigh, or arm. Patients will have several regular examinations throughout the study. Before and after the study drug is given, vital signs, ECG and physical examination will be done and blood samples and urine samples will be collected to check how they are responding to the study drug.REC name
Wales REC 2
REC reference
25/WA/0203
Date of REC Opinion
28 Aug 2025
REC opinion
Further Information Favourable Opinion