Acute Ischemic StrokePhase 2ReMEDy1NCT03290560
Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke
A Phase 2 study testing Recombinant human tissue kallikrein in people with Acute Ischemic Stroke, run by DiaMedica Therapeutics Inc at 12 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Recombinant human tissue kallikrein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 12 sitesAustralia
- Study dates
- 19 Jan 2018to 23 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Australia12 sites
Royal Adelaide Hospital
Adelaide
Ballarat Health Services
Ballarat
Box Hill Hospital
Box Hill
Royal Brisbane and Women's Hospital
Herston, Queensland
Lismore Base Hospital
Lismore, New South Wales
Liverpool Hospital
Liverpool, New South Wales
Alfred Health
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia
John Hunter Hospital
New Lambton Heights, New South Wales
Royal Melbourne Hospital
Parkville, Victoria, 3050
Sunshine Hospital
St Albans, Victoria
Princess Alexandria Hospital
Woolloongabba, Queensland
About this study
Official title: 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
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Recombinant human tissue kallikrein, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human tissue kallikreinDrug
Also called DM199
Recombinant human tissue kallikrein
PlaceboOther
Placebo Comparator: Phosphate buffered saline
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human tissue kallikrein | Experimental | A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. Receives: Drug: Recombinant human tissue kallikrein |
| Placebo | Placebo comparator | A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 Days
Secondary outcomes (3)
Changes from baseline to Day 90 of NIH Stroke Scale.
Assessed by a reduction in points from baseline.
Measured: 90 Days
Changes from baseline to Day 90 of Barthel Index.
Assessed by an increase in points from baseline.
Measured: 90 Days
Changes from baseline to Day 90 of Modified Rankin Scale.
Assessed by a reduction in points from baseline.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start19 Jan 2018
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaMedica Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Campbell, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290560
- Sponsor's protocol ID
- DM199-2017-001
- Acronym
- ReMEDy1
- Status last verified
- Feb 2020
- First submitted
- 18 Sep 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 Jul;21(6):861-870. doi: 10.1177/17474930251396480. Epub 2025 Nov 6.
PubMed 41195862
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03290560
- Acronym / sponsor ID
- ReMEDy1 / DM199-2017-001
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- DiaMedica Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant human tissue kallikrein | Experimental | Drug: Recombinant human tissue kallikreinA single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. |
| Placebo | Placebo comparator | Other: PlaceboA single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human tissue kallikreinAlso: DM199Recombinant human tissue kallikrein | Drug | Recombinant human tissue kallikrein |
| PlaceboPlacebo Comparator: Phosphate buffered saline | Other | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3
Time frame: 90 Days
Assessed by total number and severity of all treatment-related adverse events.
3 secondary outcomes
Changes from baseline to Day 90 of NIH Stroke Scale.
Time frame: 90 Days
Changes from baseline to Day 90 of Barthel Index.
Time frame: 90 Days
Changes from baseline to Day 90 of Modified Rankin Scale.
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 41195862Campbell 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. 2026 Jul;21(6):861-870. doi: 10.1177/17474930251396480. Epub 2025 Nov 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Campbell principal investigator
Melbourne Health
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human tissue kallikrein in people with Acute Ischemic Stroke, run by DiaMedica Therapeutics Inc at 12 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.