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OpenTrials
Completed

NCT Number: NCT00639249

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

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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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern General Hospital

Glasgow, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Oral administration

SA4503 Low

Drug

Oral administration

SA4503 High

Drug

Oral administration

Primary outcomes

  1. Safety and tolerability

    Time frame: 4 weeks

Secondary outcomes

  1. NIHSS

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

M's Science Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
First posted
Mar 20, 2008
Registry last updated
Jul 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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