Actively Recruiting
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
Led by EIP Pharma Inc · Updated on 2026-02-09
90
Participants Needed
12
Research Sites
4 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
Researchers are evaluating whether neflamapimod, a drug that inhibits the enzyme p38 alpha kinase, can improve physical disability and cognitive problems after moderate to severe acute ischaemic stroke. This is a phase 2, randomized, double-blind, placebo-controlled study focused on recovery following stroke in adults aged 45 and older. The study is sponsored by EIP Pharma Inc and aims to assess motor recovery and functional improvements over 12 weeks of treatment. Participants will be assigned to one of several groups receiving either neflamapimod or a placebo. The drug and placebo are given as capsules taken with food either three times daily or twice daily for 12 weeks. The study includes two cohorts with differing capsule dosing schedules. The treatment phase lasts for 12 weeks, during which the effects of neflamapimod on motor function and stroke recovery are evaluated. During the study, participants will undergo assessments including the Fugl-Meyer Assessment of Motor Recovery after Stroke, the Timed Up and Go Test, and the National Institutes of Health Stroke Scale to measure changes in motor skills and overall stroke severity. Additional measures include the Modified Rankin Scale and Barthel score to evaluate functional independence. The trial involves regular monitoring and evaluations from enrollment through the end of the 12-week treatment period.
CONDITIONS
Brief 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 aged 45 years or older at the time of signing informed consent
- Confirmed acute ischaemic stroke in the anterior circulation with symptom onset between 2 and 7 days prior to screening
- National Institutes of Health Stroke Scale (NIHSS) score between 5 and 20 inclusive with unilateral motor deficit (motor NIHSS 2 2 on affected side)
- Fugl-Meyer Assessment of Motor Recovery after Stroke total motor score of 80 or below
- No history of learning difficulties that may affect ability to complete cognitive tests
You will not qualify if you...
- Evidence of progressive or unstable stroke or intra-cerebral haemorrhage
- Planned carotid surgery within 3 months
- Major active psychiatric disorder or other medical conditions that may compromise safety or compliance
- History of alcohol or drug abuse within the previous 2 years
- Poorly controlled significant medical illnesses including high blood pressure (>180/100 mmHg), recent myocardial infarction, uncompensated heart failure, or other serious cardiovascular, pulmonary, renal, liver, infectious, immune, metabolic or endocrine disorders
- Abnormal laboratory test results outside acceptable limits as assessed by investigator including elevated liver enzymes and bilirubin (with exceptions for Gilbert's syndrome) or high INR values
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral neflamapimod or placebo capsules with food for motor recovery after acute ischaemic stroke.
Visits as scheduled during the 12-week treatment period
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
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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