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Clinical Trials in Australia / NCT06987643
Active, not recruiting Phase 2

A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke

NCT06987643 · tracked via the Priya Life Science Australia tracker
Sponsor
EIP Pharma Inc
Phase
Phase 2
Started
2025-06-20
Last updated
2026-07-08

Condition(s) studied

Moderate to Severe Acute Ischaemic StrokeIschaemic Stroke

Investigational drug(s) / intervention(s)

Neflamapimod →Placebo

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)

Trial sites (10)

FacilityCityRegionStatus
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.

View NCT06987643 on ClinicalTrials.gov ↗ ← All trials in Australia