Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke
ReMEDy1
A Randomized, Double-blind, Placebo-controlled Phase II Multi-Center Evaluation to Assess the Safety and Tolerability of DM199 Administered Intravenously and Subcutaneously in Subjects With Acute Ischemic Stroke
1 other identifier
interventional
92
1 country
12
Brief Summary
This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2020
CompletedMarch 31, 2022
February 1, 2020
2 years
September 18, 2017
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3
Assessed by total number and severity of all treatment-related adverse events.
90 Days
Secondary Outcomes (3)
Changes from baseline to Day 90 of NIH Stroke Scale.
90 Days
Changes from baseline to Day 90 of Barthel Index.
90 Days
Changes from baseline to Day 90 of Modified Rankin Scale.
90 Days
Study Arms (2)
Recombinant human tissue kallikrein
EXPERIMENTALA single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Placebo
PLACEBO COMPARATORA single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Interventions
Recombinant human tissue kallikrein
Eligibility Criteria
You may qualify if:
- Subject is \>/= 18 years of age
- Subject has been diagnosed with acute ischemic stroke with onset ≤ 24 hours from enrollment.
- Subject has NIH stroke score (NIHSS) ≥ 6 and ≤ 25.
- Subject or legally authorized representative is willing and able to sign written informed consent.
You may not qualify if:
- Subject is currently prescribed angiotensin-converting-enzyme inhibitors (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment during the active treatment period (+5 days) of the study.
- Subject has a history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis.
- Subjects with current malignancy or active malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and at least six months have elapsed since the procedure.
- Subject has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last four weeks prior to enrollment.
- Subject has clinical or laboratory evidence of an active infection at the time of enrollment.
- Subject has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
- Subject has a known diagnosis of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening.
- Subject is pregnant or nursing.
- Subject is male or female of childbearing potential, is participating in heterosexual sexual activity that could lead to pregnancy, and is unable or unwilling to practice medically effective contraception during the study.
- Subject is participating in any other investigational device or other drug study ≤ 4 weeks or 5 half-lives of the investigational product, whichever is longer.
- Subject does not have sufficient venous access for infusion of study treatment or blood sampling.
- In the opinion of the Investigator, subject is unlikely to be followed for the duration of t the study.
- Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- Subject has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
- Pre-stroke Modified Rankin Scale ≥4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Lismore Base Hospital
Lismore, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Princess Alexandria Hospital
Woolloongabba, Queensland, Australia
Alfred Health
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, Australia
Ballarat Health Services
Ballarat, Australia
Box Hill Hospital
Box Hill, Australia
Related Publications (1)
Campbell BC, Kasner SE, Lista AD, Volpi JJ, Kleinig TJ, Cordato D, Dewey HM, Choi PM, Garcia-Esperon C, Sahathevan R, Wijeratne T, Wong AA, Ghia D, Cloud GC, Giuffre M, Bath PM; ReMEDy1 Investigators. Safety and tolerability of Rinvecalinase Alfa (DM199) for acute ischemic stroke (ReMEDy1). Int J Stroke. 2025 Nov 6:17474930251396480. doi: 10.1177/17474930251396480. Online ahead of print.
PMID: 41195862DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Campbell
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 25, 2017
Study Start
January 19, 2018
Primary Completion
January 23, 2020
Study Completion
January 23, 2020
Last Updated
March 31, 2022
Record last verified: 2020-02