A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
NCT ID: NCT06987643
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-06-20
2026-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neflamapimod
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).
Neflamapimod
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo
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).
Placebo
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Interventions
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Neflamapimod
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
ALL
No
Sponsors
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CervoMed, Inc
UNKNOWN
EIP Pharma Inc
INDUSTRY
Responsible Party
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Locations
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Campbelltown Hospital
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Western Health- Sunshine Hospital
St Albans, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Ethan Gunness
Role: primary
Jordan Rogers
Role: primary
Elen Witness
Role: primary
Kristina Gee
Role: primary
Tessa Busch
Role: primary
Nicole Kristine Panerio
Role: primary
Gayleen Chappell
Role: primary
Mycah Astrera
Role: primary
Amy McDonald
Role: primary
Stefanie Bird
Role: primary
Other Identifiers
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CRVO24-NFD-601
Identifier Type: -
Identifier Source: org_study_id
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