Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

• Improvement in muscle strength and function [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions ] [ Designated as safety issue: No ]
• Change in the Mini-mental status examination [ Time Frame: Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions ] [ Designated as safety issue: No ]
• Change in balance, coordination, range of motion [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions ] [ Designated as safety issue: No ]
• Incidence of adverse events and changes in vital signs [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions ] [ Designated as safety issue: Yes ]

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.

• Drug: Magnesium Chloride
  An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
• Drug: Placebo
  A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent

• Experimental: Magnesium infusion in patients breathing 100% oxygen
  Patients will be given six infusions over three weeks. Each infusion will last between 4 and 10 minutes. They will then return to clinic in 1,2 and 3 months for the same tests (but no infusions will be given).
  Intervention: Drug: Magnesium Chloride
• Placebo Comparator: Placebo infusion
  The patients will receive six placebo infusions after which they will return to clinic at one, two and three months. At the conclusion of the trial those patients who received placebo may elect to receive the active treatment in another (open label) trial that will begin shortly after this one concludes.
  Intervention: Drug: Placebo

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