Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke

M's Science

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: SA4503 Low; Drug: placebo; Drug: SA4503 High

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639249

ME1-2

EudraCT number: 2007-004840-60

Details and patient eligibility

About

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.

Full description

Further study details as provided by M's Science Corporation:

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

P

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

A1

Experimental group

Description:

SA4503

Treatment:

Drug: SA4503 Low

A2

Experimental group

Description:

SA4503

Treatment:

Drug: SA4503 High