Acute Ischemic Stroke
Conditions
Brief summary
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., Incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs)., Incidence, severity, and causality of adverse events of special interest (AESI)., Tolerability (incidence and severity of injection site adverse reactions)., Change from Baseline in physical examination (PE) at Day 21 and Day 90., Change from Baseline in vital sign measurements (resting heart rate (HR), systolic/diastolic blood pressure (BP), respiratory rate (RR), and body temperature (BT)) at Days 1, 4, 21, and 90., Change from Baseline in hematology and chemistry parameters at Day 4, Day 21, and Day 90., Change from baseline in 12-lead Electrocardiogram (ECG) at Day 1 and Day 90 as determined by the Investigator.
Detailed description
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., 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., Mortality rate as defined by event rate (%) for mortality over 90 days., Proportion of participants achieving an excellent neurological outcome defined by NIHSS = 0-1 (dichotomized) (NIHSS scores of 0 or 1, scale range 0 to 42) at Day 90., Proportion of participants achieving an excellent functional independence in activities of daily living defined by Barthel Index score (dichotomized) greater than or equal to 95 (scale range 0 to 100) at Day 90., Recurrent AIS as defined by proportion of participants who experience a recurrent AIS by Day 90 as assessed by a new, persistent neurological deficit attributable to cerebrovascular ischemia. Imaging findings, if available, should support the diagnosis.
Interventions
DRUGcentrally blinded product containing all the same manufactured ingredients and excipients as the DM199 formulation
DRUGexcept for the active pharmaceutical ingredient (API).
Sponsors
Diamedica Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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., Incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs)., Incidence, severity, and causality of adverse events of special interest (AESI)., Tolerability (incidence and severity of injection site adverse reactions)., Change from Baseline in physical examination (PE) at Day 21 and Day 90., Change from Baseline in vital sign measurements (resting heart rate (HR), systolic/diastolic blood pressure (BP), respiratory rate (RR), and body temperature (BT)) at Days 1, 4, 21, and 90., Change from Baseline in hematology and chemistry parameters at Day 4, Day 21, and Day 90., Change from baseline in 12-lead Electrocardiogram (ECG) at Day 1 and Day 90 as determined by the Investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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., 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., Mortality rate as defined by event rate (%) for mortality over 90 days., Proportion of participants achieving an excellent neurological outcome defined by NIHSS = 0-1 (dichotomized) (NIHSS scores of 0 or 1, scale range 0 to 42) at Day 90., Proportion of participants achieving an excellent functional independence in activities of daily living defined by Barthel Index score (dichotomized) greater than or equal to 95 (scale range 0 to 100) at Day 90., Recurrent AIS as defined by proportion of participants who experience a recurrent AIS by Day 90 as assessed by a new, persistent n | — |
Countries
Belgium, France, Hungary, Poland, Romania, Spain
Outcome results
None listed