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
Qualifiers
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
Treatments tested in this trial
- Neflamapimod
- Placebo
Treatment groups
90 Participants
are divided into 4 treatment groupsSponsors and collaborators
EIP Pharma Inc
Lead sponsor
CervoMed, Inc.
Collaborator
Source ClinicalTrials.gov