Investigating the effects of neflamapimod on 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
This study is testing if the drug neflamapimod can help older adults recover better from a moderate to severe stroke by improving their movement and thinking skills.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | EIP Pharma Inc Industry-sponsored |
| Locations | 12 sites (Campbelltown, New South Wales and 11 other locations) |
| Trial ID | NCT06987643 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate whether the drug neflamapimod can enhance motor recovery and reduce cognitive dysfunction in patients who have experienced a moderate to severe acute ischaemic stroke. Participants aged 50 and older, with specific stroke characteristics and motor deficits, will be administered either neflamapimod or a placebo. The study will assess the impact of the treatment on physical and cognitive outcomes over a defined period. The goal is to determine if neflamapimod can lead to significant improvements in recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and over who have experienced a moderate to severe acute ischaemic stroke within the last week and exhibit specific motor deficits.
Not a fit: Patients with progressive or unstable strokes or those with a history of learning difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischaemic stroke.
How similar studies have performed: While this approach is novel, similar studies targeting motor recovery after stroke have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Campbelltown, New South Wales and 11 other locations
- Campbelltown Hospital — Campbelltown, New South Wales, Australia (Recruiting)
- Liverpool Hospital — Liverpool, New South Wales, Australia (Recruiting)
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia (Recruiting)
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
- Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
- Box Hill Hospital — Box Hill, Victoria, Australia (Recruiting)
- Monash Medical Centre — Clayton, Victoria, Australia (Recruiting)
- St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (Not_yet_recruiting)
- Austin Hospital — Heidelberg, Victoria, Australia (Recruiting)
- Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
- Western Health- Sunshine Hospital — St Albans, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Amanda Gardner
- Email: am.gardner@cervomed.com
- Phone: 973-452-1121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.