Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

NCT ID: NCT00933868

Last Updated: 2012-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Magnesium Chloride

Intervention Type: DRUG

An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Magnesium Chloride

An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Relox Medical, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Bert Spilker

Lead Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bert Spilker, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

President, Bert Spilker & Associates, LLC

Locations

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

Countries

United States

Other Identifiers

RM-R001

Identifier Type: -

Identifier Source: org_study_id