Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Comparison of Magnesium Chloride Infusions Versus Placebo Administered Concomitantly With 100% Oxygen Given to Patients Who Have Residual Muscle Weakness From a Stroke That Occurred Three Months to Four Years Ago

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: Magnesium Chloride; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49512
      • Born Preventive Healthcare Clinic, PC
  • New York
    • Suffern, New York, United States, 10901
      • Schachter Center for Complementary Medicine
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Comprehensive Heart Care Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Magnesium Chloride; An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Relox Medical, LLC
• Investigators: Principal Investigator: Bert Spilker, PhD, MD, President, Bert Spilker & Associates, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 30, 2009
• First Submitted That Met QC Criteria: July 3, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): May 25, 2012
• Last Update Submitted That Met QC Criteria: May 23, 2012
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: A stroke that occurred three months to four years ago
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RM-R001