Neflamapimod: Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo: Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Study summary
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.
Eligibility
Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female participants must be aged 45 years or over at the time of signing the informed consent.
* Confirmed acute ischaemic stroke in the anterior circulation (middle or anterior cerebral artery) with onset of symptoms between 2 and 7 days prior to screening and evaluation.
* National Institutes of Health Stroke Scale (NIHSS) score between 5 and 20 (inclusive) and exhibiting unilateral motor deficit (i.e. motor NIHSS ≥ 2 on affected side of the body).
* Fugl-Meyer Assessment of Motor Recovery after Ischaemic Stroke (FMMS) total motor components score of 80 or below.
* No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
Exclusion Criteria:
* Evidence of progressive or unstable stroke or intra-cerebral haemorrhage in the opinion of the investigator
* Participants needing carotid surgery within 3 months
* Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.
* History of alcohol or drug abuse within the previous 2 years.
* Poorly controlled clinically significant medical illness, such as hypertension (blood pressure \>180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety in the opinion of the Investigator.
* Abnormal laboratory tests that, in the Investigator's assessment, mean that a participant is not appropriate for participation in this study, including, but not limited to:
1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.0
× the upper limit of normal (ULN),
2. Total bilirubin \>1.5 × ULN, and/or
3. International Normalised Ratio (INR) \>1.5 NOTE: Participants with Gilbert's syndrome can be included with total bilirubin \>1.5 x ULN as long as direct bilirubin is ≤ 1.5 x ULN)
Primary outcome measure(s)
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score — From enrollment until the end of treatment at 12 weeks 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.
Change from baseline to Week 12 in the Timed Up and Go Test (TUG) — From enrollment until the end of treatment at 12 weeks 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.
Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score — From enrollment until the end of treatment at 12 weeks Scores for the NIHSS range from 0 to 42 where higher scores indicate greater impairment/worsening.
Trial sites (10)
Facility
City
Region
Status
Campbelltown Hospital
Campbelltown
New South Wales
Liverpool Hospital
Liverpool
New South Wales
Sunshine Coast University Hospital
Birtinya
Queensland
Royal Brisbane and Women's Hospital
Brisbane
Queensland
Gold Coast University Hospital
Southport
Queensland
Box Hill Hospital
Box Hill
Victoria
Austin Hospital
Heidelberg
Victoria
Alfred Hospital
Melbourne
Victoria
Royal Melbourne Hospital
Melbourne
Victoria
Western Health- Sunshine Hospital
St Albans
Victoria
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.