A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorEIP Pharma Inc
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neflamapimod
DrugNeflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo
DrugPlacebo is a capsule that looks just like neflamapimod but without the active ingredients
Treatment groups
90 Participants
are divided into 4 treatment groupsGroup A: Cohort 1 neflamapimodActive comparator 1 intervention
Group B: Cohort 1 placeboPlacebo comparator 1 intervention
Group C: Cohort 2 placeboPlacebo comparator 1 intervention
Group D: Cohort 2 neflamapimodActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score
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.
Time frame
From enrollment until the end of treatment at 12 weeks2
Change from baseline to Week 12 in the Timed Up and Go Test (TUG)
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.
Time frame
From enrollment until the end of treatment at 12 weeks3
Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score
Scores for the NIHSS range from 0 to 42 where higher scores indicate greater impairment/worsening.
Time frame
From enrollment until the end of treatment at 12 weeksSecondary outcomes
1
Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12
The mRS scores range from 0 (no symptoms) to 6 (death) where higher scores indicate greater impairment/worsening.
Time frame
From enrollment until the end of treatment at 12 weeks2
Change from baseline to Week 12 in mean Barthel score
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.
Time frame
From enrollment until the end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
EIP Pharma Inc
Lead sponsor
CervoMed, Inc.
Collaborator
Source ClinicalTrials.gov