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

M's Science Corporation0 sites60 target enrollmentOctober 16, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: M's Science Corporation
Enrollment: 60
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 16, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

M's Science Corporation

Eligibility 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) \<2 times the ULN

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