The purpose of this interventional study is to determine whether neflamapimod can improve residual physical disability and/or cognitive dysfunction after Moderate to Severe Acute Ischaemic Stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score
The FMMS test has a maximum upper motor score of 66, maximum lower motor score of 34, and a maximum total score of 212, where an increase indicates improved motor function while a decrease indicates worsening impairment.
Time frame: From enrollment until the end of treatment at 12 weeks
Change from baseline to Week 12 in the Timed Up and Go Test (TUG)
The TUG test is recorded in seconds. The test has no minimum or maximum value, and an increase in the time required to complete the TUG is a worse outcome.
Time frame: From enrollment until the end of treatment at 12 weeks
Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score
Scores for the NIHSS range from 0 to 42 where higher scores indicate greater impairment/worsening.
Time frame: From enrollment until the end of treatment at 12 weeks
Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12
The mRS scores range from 0 (no symptoms) to 6 (death) where higher scores indicate greater impairment/worsening.
Time frame: From enrollment until the end of treatment at 12 weeks
Change from baseline to Week 12 in mean Barthel score
The Barthel Index (BI) for Activities of Daily Living scores range from 0 (total dependency) to 100 (independent) where higher scores indicate greater independence/improvement.
Time frame: From enrollment until the end of treatment at 12 weeks
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Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Western Health- Sunshine Hospital
St Albans, Victoria, Australia