Moderate to Severe Acute Ischaemic Stroke, Ischaemic Stroke
Conditions
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.
Interventions
DRUGNeflamapimod
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
DRUGPlacebo
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Sponsors
EIP Pharma Inc
CervoMed, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
This is a double-blind, randomised, parallel arm, placebo-controlled, multicentre, Phase 2b exploratory study of neflamapimod in participants with moderate to severe acute ischaemic stroke. Participants enrolled into cohort 1 are randomized 1:1 (neflamapimod:placebo), dosing 3 times per day. Participants enrolled into cohort 2 are randomized 1:1 (neflamapimod:placebo), dosing 2 times per day.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score | From enrollment until the end of treatment at 12 weeks | The FMMS test has a maximum upper motor score of 66, maximum lower motor score of 34, and a maximum total score of 212, where an increase indicates improved motor function while a decrease indicates worsening impairment. |
| Change from baseline to Week 12 in the Timed Up and Go Test (TUG) | From enrollment until the end of treatment at 12 weeks | The TUG test is recorded in seconds. The test has no minimum or maximum value, and an increase in the time required to complete the TUG is a worse outcome. |
| Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score | From enrollment until the end of treatment at 12 weeks | Scores for the NIHSS range from 0 to 42 where higher scores indicate greater impairment/worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12 | From enrollment until the end of treatment at 12 weeks | The mRS scores range from 0 (no symptoms) to 6 (death) where higher scores indicate greater impairment/worsening. |
| Change from baseline to Week 12 in mean Barthel score | From enrollment until the end of treatment at 12 weeks | The Barthel Index (BI) for Activities of Daily Living scores range from 0 (total dependency) to 100 (independent) where higher scores indicate greater independence/improvement. |
Countries
Australia
Contacts
CONTACTAmanda Gardner
Outcome results
None listed