Ischemic Stroke
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.
Detailed description
Further study details as provided by M's Science Corporation:
Interventions
Sponsors
M's Science Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Males or females 18 years of age or older * Experienced a stroke from 48 to 72 hours before randomization * A total score of \>/=4 on the NIHSS, or \>/=2 on the upper or lower extremity motor scores of the NIHSS * Medically and neurologically stable within 24 hours prior to randomization Key
Exclusion criteria
* Patients with transient ischemic attack * Patients with stroke in progression * Unstable cardiac, hepatic, or renal disease, or other major medical disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS | 4 weeks |
Countries
United Kingdom
Outcome results
None listed