A Clinical Study to Investigate the Effect of Oral Neflam... | NCT06987643

Status Module

Name	Class
CervoMed, Inc.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 neflamapimod	Active Comparator	Neflamapimod will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).	Drug: Neflamapimod
Cohort 1 placebo	Placebo Comparator	Placebo will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).	Drug: Placebo
Cohort 2 placebo	Placebo Comparator	Placebo will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 2 capsules twice per day (BID) with food (i.e., with the morning and evening meals).	Drug: Placebo
Cohort 2 neflamapimod	Active Comparator	Neflamapimod will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 2 capsules twice per day (BID) with food (i.e., with the morning and evening meals).	Drug: Neflamapimod

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neflamapimod	Drug	Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules	Cohort 1 neflamapimod

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From enrollment until the end of treatment at 12 weeks
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.	From enrollment until the end of treatment at 12 weeks
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.	From enrollment until the end of treatment at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	From enrollment until the end of treatment at 12 weeks
Change from baseline to Week 12 in mean Barthel score

Eligibility Module

Eligibility 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)

Facility	Status	City	State	ZIP	Country	Contacts
Campbelltown Hospital		Campbelltown	New South Wales		Australia
Liverpool Hospital

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases