Health Trials

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

ConditionsAcute StrokeIschemic StrokeStroke
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorDiaMedica Therapeutics Inc

About this trial

This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is between 18 and 90 years of age inclusive.

Participant weight is 40 kg to 166 kg inclusive.

Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.

The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and

Disqualifiers

Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative.

Participant's initial NIHSS score prior to fibrinolytics was ≤15; and

At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and

The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recombinant human tissue kallikrein

    Drug

    DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21

  • Placebo for DM199 Solution for Injection

    Other intervention

    Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.

Treatment groups

728 Participants
are divided into 2 treatment groups
Group A: DM199Experimental treatment 1 intervention
Group B: Placebo for DM199 Solution for InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stroke Recovery

Stroke recovery as defined by participants with excellent functional outcomes at Day 90 as assessed via the Modified Rankin Score (mRS \[dichotomized\]), mRS scores of 0 or 1 represent responders, scale range of 0-6. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).

Time frame
Day 90

Secondary outcomes

1

Effect on Disability

Assessment of effect on disability across the full spectrum of AIS by examining the distribution of mRS (shift) scores (scale range = 0 to 6) at Day 90. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).

Time frame
Day 90
2

Independent Function

Proportion of participants achieving independent function (able to look after their own affairs without assistance) with or without minor disability at Day 90 assessed as mRS 0-2 (dichotomized) mRS scores of 0, 1 or 2 represent responders, scale range of 0-6. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).

Time frame
Day 90
3

Mortality Rate

Mortality rate as defined by event rate (%) for mortality over 90 days.

Time frame
Day 90
4

Neurological Outcome

Proportion of participants achieving an excellent neurological outcome defined by National Institute of Health Stroke Scale (NIHSS)= 0-1 (dichotomized) (NIHSS scores of 0 or 1, scale range 0 to 42) at Day 90. The National Institute of Health Stroke Scale (NIHSS) is a clinician-reported measure used to rate the severity of strokes, namely disability and recovery after acute stroke. The scale is comprised of 11 items with item scores ranging from 0 to 4. Total scores range from 0 to 42, with higher scores indicating increased severity.

Time frame
Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DiaMedica Therapeutics Inc

Lead sponsor

Source ClinicalTrials.gov
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