RecruitingPhase 2NCT06987643

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

A Double-Blind, Placebo-Controlled, Proof-of-Concept Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod on Recovery After Moderate to Severe Acute Ischaemic Stroke


Sponsor

EIP Pharma Inc

Enrollment

90 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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:
  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNeflamapimod

Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules

DRUGPlacebo

Placebo is a capsule that looks just like neflamapimod but without the active ingredients


Locations(12)

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

Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Monash Medical Centre

Clayton, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06987643


Related Trials