Could a pill boost brain recovery after stroke? new trial begins
NCT ID NCT06987643
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests whether a drug called neflamapimod can improve recovery of movement and thinking after a moderate to severe ischemic stroke. About 90 adults aged 45 and older will receive either the drug or a placebo for 12 weeks. The goal is to see if the drug helps reduce disability and improve daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neflamapimod (a p38 alpha kinase inhibitor)
- What this could lead to
- If it works, this could point toward a new treatment to improve physical and mental recovery after a moderate to severe stroke.
- What could go wrong
- This is an early proof-of-concept trial with only 90 people. It may fail to show benefit, and the drug's effects on stroke recovery are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alfred Hospital
Melbourne, Victoria, Australia
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Austin Hospital
Heidelberg, Victoria, Australia
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Box Hill Hospital
Box Hill, Victoria, Australia
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Campbelltown Hospital
Campbelltown, New South Wales, Australia
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Gold Coast University Hospital
Southport, Queensland, Australia
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Liverpool Hospital
Liverpool, New South Wales, Australia
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Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
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Royal Melbourne Hospital
Melbourne, Victoria, Australia
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Sunshine Coast University Hospital
Birtinya, Queensland, Australia
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Western Health- Sunshine Hospital
St Albans, Victoria, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New study tests daily checks and specialist referrals to save stroke Survivors' minds
- Common antibiotic could help stroke patients recover
- Cool heads may save brains: new stroke trial tests simple cooling method
- Can a phone app help stroke patients recover? new trial aims to find out
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