Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Comparison of Magnesium Chloride Infusions Versus Placebo Administered Concomitantly With 100% Oxygen Given to Patients Who Have Residual Muscle Weakness From a Stroke That Occurred Three Months to Four Years Ago

The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke that occurred three months to four years ago.

The hypothesis being tested is that these six treatments will improve muscle weakness and lead to an improvement in functioning/activities of daily living as measured by the 100-point Barthel index, three months after their last treatment versus their baseline measure, and that the mean difference between the treatment and placebo groups of patients will be at least three points in this index.

Inclusion Criteria:

1. Subjects of either sex above 18 years of age
2. Documented history of stroke 3 months to four years ago
3. Subjects may have had two or more strokes
4. Must have residual muscle weakness with a 25% or greater difference in strength between the right and left sides of the body
5. Must be assessed as a 2 or 3 on the Modified Rankin Scale
6. Must have a Barthel score at or below 85

Exclusion Criteria:

1. Any traumatic brain injury or other brain injury apart from stroke
2. Renal insufficiency or renal failure
3. Any medical or physical condition that would interfere with the measurements to be conducted
4. Any physical therapy in a facility outside their home within three days of screening