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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
Recombinant human tissue kallikrein
Placebo Comparator: Phosphate buffered saline
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
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.
Time frame: 90 Days
Changes from baseline to Day 90 of NIH Stroke Scale.
Assessed by a reduction in points from baseline.
Time frame: 90 Days
Changes from baseline to Day 90 of Barthel Index.
Assessed by an increase in points from baseline.
Time frame: 90 Days
Changes from baseline to Day 90 of Modified Rankin Scale.
Assessed by a reduction in points from baseline.
Time frame: 90 Days
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Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Princess Alexandria Hospital
Woolloongabba, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, Australia
...and 2 more locations