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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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P

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral administration

A1

SA4503

Group Type EXPERIMENTAL

SA4503 Low

Intervention Type DRUG

Oral administration

A2

SA4503

Group Type EXPERIMENTAL

SA4503 High

Intervention Type DRUG

Oral administration

Interventions

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placebo

Oral administration

Intervention Type DRUG

SA4503 Low

Oral administration

Intervention Type DRUG

SA4503 High

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* Patients with transient ischemic attack
* Patients with stroke in progression
* Unstable cardiac, hepatic, or renal disease, or other major medical disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No