A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke

NCT06987643 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CRVO24-NFD-601
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 12

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.

Conditions

Ischaemic Stroke; Moderate to Severe Acute Ischaemic Stroke

Outcome Measures

Primary Outcomes (3)

• 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 (2)

• Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12

  From enrollment until the end of treatment at 12 weeks

• Change from baseline to Week 12 in mean Barthel score

  From enrollment until the end of treatment at 12 weeks

Study Arms (4)

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

Neflamapimod DRUG

Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules

Also known as: VX-745

Cohort 1 neflamapimod; Cohort 2 neflamapimod

Placebo DRUG

Placebo is a capsule that looks just like neflamapimod but without the active ingredients

Cohort 1 placebo; Cohort 2 placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.0
• × the upper limit of normal (ULN),
• Total bilirubin \>1.5 × ULN, and/or
• 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)

Sponsors & Collaborators

• EIP Pharma Inc: lead
• CervoMed, Inc: collaborator

Study Sites (12)

Campbelltown Hospital

Campbelltown, New South Wales, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, Australia

RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

RECRUITING

Gold Coast University Hospital

Southport, Queensland, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, Australia

RECRUITING

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

NOT YET RECRUITING

Austin Hospital

Heidelberg, Victoria, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

RECRUITING

Western Health- Sunshine Hospital

St Albans, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

VX-745

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Amanda Gardner

CONTACT

973-452-1121; am.gardner@cervomed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. Participants enrolled into cohort 1 are randomized 1:1 (neflamapimod:placebo), dosing 3 times per day. Participants enrolled into cohort 2 are randomized 1:1 (neflamapimod:placebo), dosing 2 times per day.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 23, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (12)