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

Prior treatment

• 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.

Other illness

• Evidence of progressive or unstable stroke or intra-cerebral haemorrhage in the opinion of the investigator
• 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.

Lab values

• 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:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.0
  • × the upper limit of normal (ULN),
  • Total bilirubin \>1.5 × ULN, and/or
  • 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)

• 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.