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

Launched by EIP PHARMA INC · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called neflamapimod to see if it can help people recover better from physical and mental challenges after having a moderate to severe acute ischaemic stroke. An acute ischaemic stroke occurs when blood flow to the brain is blocked, leading to brain damage. The goal of the study is to find out if taking this medication can improve patients' physical abilities and cognitive functions, which refers to how well they think and process information.

To participate in the trial, individuals must be 50 years or older and have experienced a stroke within the last 2 to 7 days. They should have certain levels of physical and cognitive impairment as measured by specific tests. However, those with serious ongoing health conditions or certain medical histories, such as significant psychiatric disorders or recent major surgeries, will not be able to participate. If someone joins the study, they can expect to take the medication and undergo regular assessments to monitor their recovery and overall health during the trial. This study is currently recruiting participants, and everyone, regardless of gender, is welcome to apply.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female participants must be aged 50 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 ≥ 5 on affected side of the body).
• • Fugl-Meyer Assessment of Motor Recovery after Ischaemic Stroke (FMMS) total motor components score of 80 or below.
• • Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
• • 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)