Език: EN EN
← Назад към резултатите
Набира участници Фаза 2 NCT06987643

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Moderate to Severe Acute Ischaemic Stroke Ischaemic Stroke

Спонсор: EIP Pharma Inc

Налично на: БГ
Обобщение
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.
Кой може да участва
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)
Места на провеждане 1
Австралия (1)
Campbelltown Hospital
Campbelltown , New South Wales
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
45 Years
Здрави доброволци
Не
Начална дата
20.06.2025
Крайна дата
28.06.2026
Регистрационен номер
NCT06987643
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.