Clinical trial NCT06987643: A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Moderate to Severe Acute Ischaemic Stroke
Ischaemic Stroke
Lead sponsor: EIP Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: CervoMed, Inc
First posted: 2025-05-23
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Male or female participants must be aged 50 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 ≥ 5 on affected side of the body).
* Fugl-Meyer Assessment of Motor Recovery after Ischaemic Stroke (FMMS) total motor components score of 80 or below.
* Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
* 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)

Primary outcomes:
measure: Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS)
timeFrame: From enrollment until the end of treatment at 12 weeks
measure: Change from baseline to Week 12 in the Timed Up and Go Test (TUG)
timeFrame: From enrollment until the end of treatment at 12 weeks
measure: Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score
timeFrame: From enrollment until the end of treatment at 12 weeks
Secondary outcomes:
measure: Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12
timeFrame: From enrollment until the end of treatment at 12 weeks
measure: Change from baseline to Week 12 in mean Barthel score
timeFrame: From enrollment until the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: St Albans
country: Australia
facility: Western Health- Sunshine Hospital
state: Victoria
Study officials:
References: