Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Magnesium Chloride

• Registration Number: NCT00933868
• Lead Sponsor: Relox Medical, LLC

Brief Summary

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-07-03
• Study First Posted: 2009-07-07
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo infusion	Placebo	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 infusion in patients breathing 100% oxygen	Magnesium Chloride	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).

Primary Outcome Measures

Name	Time	Method
Barthel Index	Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (3)

Born Preventive Healthcare Clinic, PC; 🇺🇸 Grand Rapids, Michigan, United States

Schachter Center for Complementary Medicine; 🇺🇸 Suffern, New York, United States

Comprehensive Heart Care Inc.; 🇺🇸 Toledo, Ohio, United States