A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Phase IIa Study of Safety and Motor Function Restoration in Subjects Treated with SA4503 following Acute Ischemic Stroke
- Conditions
- Acute Ischemic StrokeMedDRA version: 9.1Level: LLTClassification code 10055221Term: Ischemic stroke
- Registration Number
- EUCTR2007-004840-60-CZ
- Lead Sponsor
- M's Science Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
• 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 patient is not competent to give consent, informed consent and commitment to study procedures may be given by the patient’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 less than or equal to 4 on the NIHSS, or of greater than or equal to 2 on the upper or 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 <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 patient’s condition)
• Have lab values within the following limits:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) <2 times the upper limit of normal (ULN)
- Bilirubin less than or equal to1.5 times the ULN
- Haemoglobin greater than or equal to 9.0 gm/dL
- Platelet count greater than or equal to 100,000/mm3
- Creatinine clearance >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
• 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 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
- MI (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 patient'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 (evidenced as creatinine clearance of <50 mL/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 enrolment
• 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 judgment could jeopardize the patient’s participation in this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>
- Secondary Outcome Measures
Name Time Method