Actively Recruiting
A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
Led by EIP Pharma Inc · Updated on 2026-02-09
90
Participants Needed
12
Research Sites
53 weeks
Total Duration
On this page
Sponsors
E
EIP Pharma Inc
Lead Sponsor
C
CervoMed, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 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.
You will not qualify if you...
- 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 might compromise safety and/or compliance.
- History of alcohol or drug abuse within the previous 2 years.
- Poorly controlled significant medical illnesses such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic), recent myocardial infarction within 6 months, uncompensated congestive heart failure, or other significant cardiovascular, pulmonary, renal, liver, infectious, immune, metabolic/endocrine disorders.
- Abnormal laboratory tests including:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.0 times the upper limit of normal (ULN),
- Total bilirubin >1.5 times ULN,
- International Normalised Ratio (INR) >1.5 (participants with Gilbert's syndrome may be included if direct bilirubin 2 1.5 times ULN).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Actively Recruiting
2
Liverpool Hospital
Liverpool, New South Wales, Australia
Actively Recruiting
3
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Actively Recruiting
4
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Actively Recruiting
5
Gold Coast University Hospital
Southport, Queensland, Australia
Actively Recruiting
6
Box Hill Hospital
Box Hill, Victoria, Australia
Actively Recruiting
7
Monash Medical Centre
Clayton, Victoria, Australia
Actively Recruiting
8
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Not Yet Recruiting
9
Austin Hospital
Heidelberg, Victoria, Australia
Actively Recruiting
10
Alfred Hospital
Melbourne, Victoria, Australia
Actively Recruiting
11
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Actively Recruiting
12
Western Health- Sunshine Hospital
St Albans, Victoria, Australia
Actively Recruiting
Research Team
A
Amanda Gardner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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