Status:

RECRUITING

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

Lead Sponsor:

EIP Pharma Inc

Collaborating Sponsors:

CervoMed, Inc

Conditions:

Moderate to Severe Acute Ischaemic Stroke

Ischaemic Stroke

Eligibility:

All Genders

45+ years

Phase:

PHASE2

Brief 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 Criteria

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)

Key Trial Info

Start Date :

June 20 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 28 2026

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT06987643

Start Date

June 20 2025

End Date

June 28 2026

Last Update

February 9 2026

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Campbelltown Hospital

Campbelltown, New South Wales, Australia

2

Liverpool Hospital

Liverpool, New South Wales, Australia

3

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

4

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia