Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Completed

Phase 2/3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Placebo infusion
    Description: 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.
  • Magnesium Chloride Drug
    Intervention Desc: An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
    ARM 1: Kind: Experimental
    Label: Magnesium infusion in patients breathing 100% oxygen
    Description: 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).

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Barthel Index Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions No
Secondary Improvement in muscle strength and function Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions No
Secondary Change in the Mini-mental status examination Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions No
Secondary Change in balance, coordination, range of motion Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions No
Secondary Incidence of adverse events and changes in vital signs Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions Yes

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