Moderate to Severe Acute Ischaemic StrokePhase 2RESTORENCT06987643
A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
A Phase 2 study testing Neflamapimod in people with Moderate to Severe Acute Ischaemic Stroke and Ischaemic Stroke, run by EIP Pharma Inc at 10 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Moderate to Severe Acute Ischaemic Stroke, Ischaemic Stroke
- What is being tested?
- Neflamapimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 10 sitesAustralia
- Study dates
- 20 Jun 2025to 6 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
Sunshine Coast University Hospital
Birtinya, Queensland
Box Hill Hospital
Box Hill, Victoria
Royal Brisbane and Women's Hospital
Brisbane, Queensland
Campbelltown Hospital
Campbelltown, New South Wales
Austin Hospital
Heidelberg, Victoria
Liverpool Hospital
Liverpool, New South Wales
Alfred Hospital
Melbourne, Victoria
Royal Melbourne Hospital
Melbourne, Victoria
Gold Coast University Hospital
Southport, Queensland
Western Health- Sunshine Hospital
St Albans, Victoria
About this study
Official title: A Double-Blind, Placebo-Controlled, Proof-of-Concept Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod on Recovery After Moderate to Severe Acute Ischaemic Stroke
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.
- Being tested
- Neflamapimod, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeflamapimodDrug
Also called VX-745
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
PlaceboDrug
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Neflamapimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The mRS scores range from 0 (no symptoms) to 6 (death) where higher scores indicate greater impairment/worsening.
Measured: 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.
Measured: From enrollment until the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start20 Jun 2025
- Primary completion23 Sep 2026
- Study completion6 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Acute Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- EIP Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CervoMed, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987643
- Sponsor's protocol ID
- CRVO24-NFD-601
- Acronym
- RESTORE
- Status last verified
- Oct 2026
- First submitted
- 5 May 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Proof-of-Concept Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod on Recovery After Moderate to Severe Acute Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT06987643
- Acronym / sponsor ID
- RESTORE / CRVO24-NFD-601
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- EIP Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- CervoMed, Inc.
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 6 Oct 2026 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 neflamapimod | Active comparator | Drug: NeflamapimodNeflamapimod 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). |
| Cohort 1 placebo | Placebo comparator | Drug: PlaceboPlacebo 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). |
| Cohort 2 placebo | Placebo comparator | Drug: PlaceboPlacebo 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). |
| Cohort 2 neflamapimod | Active comparator | Drug: NeflamapimodNeflamapimod 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). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeflamapimodAlso: VX-745Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules | Drug | Cohort 1 neflamapimod, Cohort 2 neflamapimod |
| PlaceboPlacebo is a capsule that looks just like neflamapimod but without the active ingredients | Drug | Cohort 1 placebo, Cohort 2 placebo |
Primary outcome
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score
Time frame: From enrollment until the end of treatment at 12 weeks
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.
Change from baseline to Week 12 in the Timed Up and Go Test (TUG)
Time frame: From enrollment until the end of treatment at 12 weeks
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.
Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score
Time frame: From enrollment until the end of treatment at 12 weeks
Scores for the NIHSS range from 0 to 42 where higher scores indicate greater impairment/worsening.
2 secondary outcomes
Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12
Time frame: From enrollment until the end of treatment at 12 weeks
Change from baseline to Week 12 in mean Barthel score
Time frame: From enrollment until the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Moderate to Severe Acute Ischaemic Stroke
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Acute Ischemic Stroke
Not yet recruitingPhase 4
Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke
Ischemic Stroke, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neflamapimod in people with Moderate to Severe Acute Ischaemic Stroke and Ischaemic Stroke, run by EIP Pharma Inc at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score (time frame: From enrollment until the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.