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
50+ 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
- 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
- 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)
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
September 30 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
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
Gold Coast University Hospital
Southport, Queensland, Australia