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

EIP Pharma

Status and phase: Enrolling; Phase 2

Conditions: Ischaemic Stroke; Moderate to Severe Acute Ischaemic Stroke

Treatments: Drug: Placebo; Drug: Neflamapimod

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06987643

CRVO24-NFD-601

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Neflamapimod

Active Comparator group

Description:

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).

Treatment:

Drug: Neflamapimod

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo