Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Relox Medical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke

Treatments: Drug: Magnesium Chloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00933868

RM-R001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Magnesium infusion in patients breathing 100% oxygen

Experimental group

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).

Treatment:

Drug: Magnesium Chloride

Placebo infusion

Placebo Comparator group

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.

Treatment:

Drug: Placebo