Acute Ischemic Stroke MedDRA version: 9.1 Level: LLT Classification code 10055221 Term: Ischemic stroke
Conditions
Interventions
Product Name: SA4503
Product Code: SA4503
Pharmaceutical Form: Capsule, hard
CAS Number: 165377-44-6
Current Sponsor code: SA4503
Concentration unit: mg milligram(s)
Concentration type: up to
Concentr
Sponsors
M's Science Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Are males or females 18 years of age or older • Are willing and competent to give informed consent, and are willing and able to comply with the protocol procedures. If a subject is not competent to give consent, informed consent and commitment to study procedures may be given by the subject’s legal representative in cooperation with an independent physician • Have experienced a stroke from 48 to 72 hours before randomization • Have an ischemic stroke. Computed tomography (CT) or magnetic resonance imaging (MRI) findings must be consistent with a diagnosis of stroke, including evidence of fresh ischemic lesions (minor asymptomatic haemorrhagic conversion acceptable). • Significant impairment of neurological function, defined as a total score of greater than or equal to 4 on the NIHSS, or greater than or equal to 2 on the upper and lower extremity motor function scores (Questions 5 and 6) of the NIHSS. • Can reasonably be expected to be available for all study visits • Previously independent as confirmed by a score of less than 2 on the Modified Rankin Scale. • Are medically and neurologically stable within 24 hours prior to randomization (including stable neurological exam, normal or normalizing complete blood count (CBC) and urinalysis, stable vital signs, lack of myocardial infarction (MI), afebrile, and the Investigator’s judgment as to stability of the subject’s condition) • Have lab values within the following limits: - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) 50 mL/min. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Are pregnant or breast feeding • Are of child-bearing potential and unwilling to use adequate birth control (i.e. abstinence from heterosexual intercourse or use of an intrauterine device in combination with a barrier method, e.g. diaphragm or condom, and spermicide) for the duration of the study (please refer to Section 7.1.4 of the protocol for further details). • Are currently receiving anti-epileptic agents, anxiolytic agents (except for benzodiazepines in stable doses that were started prior to the stroke, or short term in the first hours after admission to the hospital), amphetamines, or the sigma-1 receptor agents or medications inhibiting CYP 3A4 or CYP 2D6 as described in Appendix A of the protocol. • Are patients with transient ischemic attack (TIA) • Are patients with stroke in progression • Have received anti-psychotic medications within the previous 6 months • Have a prior history of: - Seizure or suspected seizure - Head injury with loss of consciousness (within the past year) - Head injury due to penetrating wound - Abnormal motor function (prior to stroke) - Dementia - Myocardial infarction (within the last 6 months) - Hospitalization for major psychiatric illness (within the last 5 years) - Evidence of alcohol or drug dependence or abuse which, based on the Investigator's judgment, may affect the subject's ability to participate in this trial - Any major surgical intervention within last 6 months - Diagnosis or evidence of chronic hepatitis or human immunodeficiency virus (HIV) • Have current conditions of: - Unstable cardiac, hepatic, or renal disease (as evidenced by creatinine clearance of <50mL/min), or other major medical disorder - Terminal illness - Severe neurological diseases other than stroke • Have participated in any study of an investigational drug, device, or other treatment within 30 days prior to enrollment • Are unable to take medication by mouth (i.e., are using a feeding tube) at the time of Baseline assessments • Have any condition that upon the Investigator's judgement could jeopardise the patient's participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and tolerability of 2 dose levels of SA4503 (1 mg and 3 mg per day) in comparison to placebo treatment in subjects recovering from a recent stroke;Secondary Objective: Evaluate the efficacy of SA4503 (1 mg and 3 mg per day) in comparison to placebo treatment in restoring general neurological functioning, as measured by the National Institutes of Health Stroke Scale (NIHSS), in subjects recovering from a recent stroke;Primary end point(s): Efficacy analyses will evaluate change in efficacy values from Baseline to the end of the treatment period (Day 28) and from Baseline to the Study Completion Visit (Day 56) by using analysis of covariance (ANCOVA). Factors will include treatment (placebo, 1 mg SA4503, or 3 mg SA4503), with Baseline scores, amount of rehabilitation, patient age, and timing of treatment initiation after stroke onset as covariates | — |
Countries
Czech Republic, United Kingdom
Outcome results
None listed