A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke
- Conditions
- Moderate to Severe Acute Ischaemic StrokeIschaemic Stroke
- Interventions
- Drug: Placebo
- Registration Number
- NCT06987643
- Lead Sponsor
- EIP Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Male or female participants must be aged 50 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 ≥ 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.
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Evidence of progressive or unstable stroke or intra-cerebral haemorrhage in the opinion of the investigator
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Participants needing carotid surgery within 3 months
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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.
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History of alcohol or drug abuse within the previous 2 years.
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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.
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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),
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Total bilirubin >1.5 × ULN, and/or
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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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neflamapimod 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). Placebo 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).
- Primary Outcome Measures
Name Time Method Change from baseline to Week 12 in the Timed Up and Go Test (TUG) 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 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.
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) From enrollment until the end of treatment at 12 weeks The FMMS test has a maximum score of 212 and an increase indicates improved motor function while a decrease indicates worsening impairment.
- Secondary Outcome Measures
Name Time Method Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12 From enrollment until the end of treatment at 12 weeks The mRS scores range from 0 (no symptoms) to 6 (death) where higher scores indicate greater impairment/worsening.
Change from baseline to Week 12 in mean Barthel score From enrollment until the end of treatment at 12 weeks 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.
Trial Locations
- Locations (10)
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
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