A Phase 2 interventional study of Neflamapimod and Placebo in Moderate to Severe Acute Ischaemic Stroke and Ischaemic Stroke, sponsored by EIP Pharma Inc. Active, not recruiting at 10 sites in Australia. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by EIP Pharma Inc · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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),
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
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
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
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
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
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment until the end of treatment at 12 weeks
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.
Time frame: From enrollment until the end of treatment at 12 weeks
Change from baseline to Week 12 in mean Barthel score
The Barthel Index (BI) for Activities of Daily Living scores range from 0 (total dependency) to 100 (independent) where higher scores indicate greater independence/improvement.
Time frame: From enrollment until the end of treatment at 12 weeks
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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EIP Pharma Inc